*UPGRADE IN PROGRESS* -- CareerCircle platform upgrades will occur between Monday June 27th 10PM Eastern Time through Tuesday June 28th 4AM Eastern Time.&nbsp; The system may be intermittently unavailable during this timeframe.&nbsp;&nbsp;

*UPGRADE IN PROGRESS* -- CareerCircle is upgrading its capabilities and as a result the system may be temporarily unavailable as we bring new capabilities and infrastructure online to better serve our members.&nbsp; If you receive an error during this timeframe please bear with us as we're working to improve our system and you may need to retry that operation at a later time.&nbsp; &nbsp;

Job Description This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, company policies and procedures and with quality standards internally and externally. Under the oversight of the CRD(Clinical Research Director) / Director, Clinical Research, the individual is responsible to manage/oversee a team of CTCs(Clinical Trial Coordinator). As line manager the role is critical to continuously develop future talent by providing training, support and mentoring to the CTCs, as well as for interns delegated to the Clinical Operations team based on the Internship program, while properly managing situations of low or non-performance. The role will work across the different country operations roles (e.g. CRM(Clinical Research Manager), CRA(Clinical Research Associate)-Manager, Partners, TA-Head, CRD and Sr.COM) to ensure alignment and development of the country CTC capabilities. The person contributes to CTC capacity/resource planning activities to ensure efficient allocation of resources and work. Responsibilities include, but are not limited to:<ul><li>Has significant impact on how a country can deliver country-specific trial </li><li>commitments and objectives especially during study start-up.</li><li>Ensure and oversee proper on-boarding and off-boarding of employees, compliance to initial and ongoing trainings.</li><li>Train and oversee the CORE competencies, ICH-GCP knowledge, Clinical Research environment etc.</li><li>Assure adherence to GCP guidelines, processes and procedures related to direct reports' activities and performance.</li><li>Ensure direct reports are compliant to the timelines and key business metrics.</li><li>Review and approve timesheets, GTT compliance, expense reports, time-off requests and provide proper oversight of CTC's productivity/utilization.</li><li>Provide input for capacity planning, including reporting of current manpower and forecasting of CTC capacity and needs, to provide efficient use of resources.</li><li>Work with CRDs, TA-Heads, CRMs, CRA-Manager, Sr. COM, CRAs, Partners and </li><li>other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.</li><li>Interacts with CRMs and sites as needed to resolve operational issues, to</li><li>meet commitments in a timely manner and in coordination with the study</li><li>CRM and CRA.</li><li>Interface with GCTO(Global Clinical Trial Operations) partners on clinical trial execution as assigned; including acts as lead liaison with CTC FSP partners in facilitating coordinated process and country delivery.</li><li>Escalates site performance issues to CRM and CRD/TA-Head.</li><li>People and Resource Management:</li><li>Manages CTC - career development, performance reviews, </li><li>etc., including addressing low performance situations, and taking </li><li>appropriate actions.</li><li>Supports and resolves escalation of issues from CTCs.</li><li>Manages capacity/resource planning activities to ensure efficient allocation</li><li>of resources and work. Manage local conflicts between resource and work.</li><li>Ensures CTC compliance to corporate policies, procedures and quality standards.</li></ul>Skills:<ul><li>Demonstrates proactive leadership and must be able to in/directly influence vendors, external partners and country managers to deliver these commitments within specified timelines with minimal oversight from the line manager. </li><li>Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. He/she is an independent decision maker with a clear understanding.</li><li>of the pros and cons of each decision and takes ownership of decisions</li><li>Ability to work independently and in a team environment.</li><li>Excellent people management, time management, project management and </li><li>organizational skills.</li><li>History of strong performance and leadership.</li><li>Skills and judgment required to be a good steward/decision maker for the company.</li><li>Fluent in Local Language and business proficient in English (verbal and written).</li><li>Excellent working knowledge of all applicable ICH/GCP regulations and </li><li>Good Documentation Practices and ability to work within these guidelines</li><li>Expertise in and excellent working knowledge of core trial management systems and tools.</li><li>Strong coordination and organizational skills.</li><li>High emotional intelligence.</li><li>Strong leadership skills with proven success in people management</li><li>Excellent interpersonal and communication skills, conflict management</li><li>Demonstrated ability to build relationships and to communicate effectively with internal stakeholders and external partners.</li><li>Fluency in both English and local language.</li><li>Advanced Microsoft Excel skills for the purposes of data analysis</li></ul>Qualification & Experience:<ul><li>Minimum of 5 years experience within Clinical Research, preferred experience in the role of CTC, CRA or similar role.</li><li>Line management experience preferred or at the minimum team leader experience.</li></ul>Educational Requirements: Required:<ul><li>Bachelor's Degree (or comparable) in Business Administration/ Life Science </li></ul>Preferred:<ul><li>Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or Clinical Research Management/Administration.</li></ul>#MRLGCTO #eligibleforERP NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $135,500.00 - $213,400.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Remote Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/28/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/28/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295927

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Clinical Trial Coordinator Manager (CTC Manager) - REMOTE

Job Description Our company's Sterile & Specialty Products (SSP) department is a multidisciplinary research group responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies to commercialization. Driving drug product design from the bench to manufacturing facilities, our teams ensure robust product design and development through deep fundamental understanding and characterization including screening and designing drug product compositions, developing scalable processes, and defining primary packaging / device. During development, we leverage smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation, and process selection. We are seeking a motivated engineer / scientist to work collaboratively in a team environment to help solve key challenges in formulation development and manufacturing of parenteral pharmaceutical products. The successful candidate will be a passionate scientist with strong academic fundamentals and a drive to develop new medicines to improve human health. In this role, the individual will be responsible for supporting the formulation development of new biological / chemical entities as part of a matrix team from initial first-in-human formulations to commercialization. The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Additional Responsibilities: <ul><li> Develops and applies basic principles and scientific concepts to execute work in a laboratory or pilot plant environment to develop sterile drug products. </li><li> Capable of learning practical laboratory / pilot plant skills and fundamental scientific principles to utilize as part of their daily responsibilities. </li><li> Executes routine experiments and data interpretation with appropriate technical guidance. Operates and troubleshoots equipment and processes. </li><li> Builds capability to support manufacturing operations in GXP environments. </li><li> Can understand overall project timelines to manage prioritization of individual contributor deliverables with appropriate supervision. </li><li> Works well with others in collaborative team environments. </li><li> Takes initiative, motivated to excel, has a strong technical background, has excellent communication and interpersonal skills. </li><li> Builds awareness of relevant new and current technologies to grow as a pharmaceutical scientist. </li></ul> Education Minimum Requirements: <ul><li> B.S. and/or M.S degree in Chemical / Biochemical / Biomedical Engineering, Materials Science, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or related fields </li></ul> Required Experience and Skills: <ul><li> Strong verbal and written communication skills. </li><li> Strong collaboration skills and experience working in a team environment. </li><li> Ability to learn and apply new scientific principles to execution of daily responsibilities. </li><li> Demonstrated ability to collate and conduct basic data analysis. </li><li> Prior experience with Microsoft Office. </li></ul> Preferred Experience and Skills: <ul><li> Prior experience in a laboratory environment. </li><li> Passion to learn and develop as a pharmaceutical scientist. </li></ul>#eligibleforERP NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $68,400.00 - $107,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/4/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/04/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295622

Associate Scientist, Sterile and Specialty Products

Job Description Our company's Sterile & Specialty Products (SSP) department is a multidisciplinary research group responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies to commercialization. Driving drug product design from the bench to manufacturing facilities, our teams ensure robust product design and development through deep fundamental understanding and characterization including screening and designing drug product compositions, developing scalable processes, and defining primary packaging / device. During development, we leverage smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation, and process selection. We are seeking a motivated and experienced engineer / scientist to work collaboratively in a team environment to help solve key challenges in formulation development and manufacturing of parenteral pharmaceutical products. The successful candidate will be a passionate scientist with strong academic fundamentals and a drive to develop new medicines to improve human health. In this role, the individual will be responsible for supporting the formulation development of new biological / chemical entities as part of a matrix team from initial first-in-human formulations to commercialization. The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Additional Responsibilities: <ul><li> Develops and applies basic principles and scientific concepts to execute work in a laboratory or pilot plant environment to develop sterile drug products. </li><li> Capable of learning practical laboratory / pilot plant skills and fundamental scientific principles to utilize as part of their daily responsibilities. </li><li> Executes routine experiments and data interpretation with appropriate technical guidance. Operates and troubleshoots equipment and processes. </li><li> Builds capability to support manufacturing operations in GXP environments. </li><li> Can understand overall project timelines to manage prioritization of individual contributor deliverables with appropriate supervision. </li><li> Works well with others in collaborative team environments. </li><li> Takes initiative, motivated to excel, has a strong technical background, has excellent communication and interpersonal skills. </li><li> Builds awareness of relevant new and current technologies to grow as a pharmaceutical scientist. </li></ul> Education Minimum Requirements: <ul><li> B.S. degree in Chemical / Biochemical / Biomedical Engineering, Materials Science, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or related fields plus 3 years of industry experience OR a MS degree with some relevant experience </li></ul> Required Experience and Skills: <ul><li> Strong verbal and written communication skills. </li><li> Strong collaboration skills and experience working in a team environment. </li><li> Ability to learn and apply new scientific principles to execution of daily responsibilities. </li><li> Demonstrated ability to collate and conduct basic data analysis. </li><li> Prior experience with Microsoft Office. </li></ul> Preferred Experience and Skills: <ul><li> Prior experience in a laboratory environment. </li><li> Passion to learn and develop as a pharmaceutical scientist. </li></ul>#eligibleforERP NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $83,100.00 - $130,900.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/4/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/04/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295663

Scientist, Sterile and Specialty Products

Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Bio-Technician, Level 1/2 Responsibilities: <ul><li>Following the appropriate SOPs, MPDs and other pertinent documentation, performs all functions required to produce vaccines.</li><li>Maintains production records, physical inventory and accounting reports, instructs and directs assigned personnel; maintains in-process checks and assists in developmental work pertaining to production methods when required. Documents all work according to proper cGMP documentation practices and performs review of manufacturing documentation.</li><li>Performs all work duties via automated systems or manual operations in compliance with safe operating procedures, company and government regulations, and good manufacturing practices.</li><li>Process monitoring documentation and process review will be completed as required to ensure that only the highest quality product is released.</li><li>Cleans, assembles, operates, disassembles, maintains, trouble shoots and initiates corrective actions as required to meet production schedules.</li><li>Trains personnel on approved processes and procedures.</li><li>Dispose of Process waste material as per departmental SOP and regulatory guidelines.</li></ul>Equipment (including, but not limited to):<ul><li>ANALYTICAL EQUIPMENT ( e.g. pH meters, conductivity meters, spectrophotometer, pipettes, off-gas analyzer and Biolyzer)</li><li>AUTOMATED SYSTEMS (e.g. DCS, robotics)</li><li>CIP SYSTEMS (automated and manual)</li><li>CLEANING EQUIPMENT AND SUPPLIES (e.g. mops and disinfectants)</li><li>DECONTAMINATION EQUIPMENT (e.g. autoclaves and tanks)</li><li>IDENTIFICATION SYSTEMS (e.g. labeling devices)</li><li>MAINTENANCE EQUIPMENT (e.g. tools and calibration equipment)</li><li>MATERIAL HANDLING EQUIPMENT (e.g. hand jacks, carts, hand trucks, hoists, biosafety cabinets, chemical fume hoods, freezers, thaw baths and pumps)</li><li>PROCESS VESSELS (e.g. tanks, fermentors, portable banks, bags and bottles)</li><li>SEPARATION SYSTEMS (e.g. filters, centrifuges, and chromatography equipment)</li><li>WEIGHMENT SYSTEMS (e.g. scales, balances)</li><li>ENVIRONMENTAL MONITORING EQUIPMENT (e.g. SMA, particle counters)</li><li>COMPUTER SYSTEMS (e.g. IMPACT, NGL, HanDEL)</li><li>SPECIAL LABORATORY EQUIPMENT (e.g. microscopes, centrifuge, pumps)</li></ul>Duties:<ul><li>Working in conjunction with all appropriate personnel, performs manual and automated</li><li>operations, general maintenance and support functions necessary for the production of vaccines.</li><li>Participates in and assists with the development and execution of personnel training.</li><li>Revises and authors SOPs and GMP documentation.</li><li>Serves on safety, quality and other committees as required.</li><li>Provides all documentation and clerical functions necessary to allow proper accountability and traceability of product.</li><li>Maintains, inventories, and transports all required equipment, materials, supplies and products. Ensures shipment criteria and timely availability and delivery.</li><li>Demonstrates proficiency with Distributed Control System and other automated systems (including, but not limited to, NGL, WATS, HanDEL, Word, Excel, and IMP ACT)..</li><li>Performs general maintenance and assists in troubleshooting of equipment.</li><li>Performs housekeeping in all work areas. Executes facility decontamination according to approved procedures.</li><li>Performs sampling/in-process testing supporting the manufacturing and validation processes for current process as well as developmental work for new products/processes as required..</li><li>At the start and finish of each shift, reports and makes recommendations regarding equipment supplies, required repairs, process concerns, safety concerns, and area for improvements.</li><li>Immediately notifies the appropriate personnel of compliance, environmental, safety, and process deviations.</li><li>Maintains, cleans and prepares equipment used in vaccine production.</li><li>Schedules and performs environmental monitoring during processing and records results in the computerized database system.</li><li>Performs all job functions of Support Associate or Clerk positions as required.</li><li>Delivers all samples and other materials as required to appropriate laboratories.</li><li>Attends and actively participates in HAZOPS, waste walkthroughs, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required.</li></ul>Level I employees will be systematically trained in the following skills. Once proficiency has been demonstrated in a skill, employees will be responsible for performing these skills as required. Demonstrated proficiency in ALL skills is required for promotion to Level 2. <ul><li>Process operations, in process testing, and in process maintenance/system checks</li><li>Document Review and basic math skills</li><li>Utilization of material and financial system (eg. IMPACT)</li><li>Utilization of automated systems ( e.g. NGL, HanDEL, WATS)</li><li>Utilization oflaboratory and manufacturing equipment</li><li>Environmental Monitoring (including: scheduling, sampling, and data review)</li><li>Inventory management and stocking Housekeeping and cleaning</li><li>Safety and cGMPs including involvement in systems to maintain and improve compliance</li></ul>Education:<ul><li>Minimum bachelor's degree in chemistry, biology, biochemistry, microbiology, molecular biology or life sciences, chemical, biochemical engineering or other relevant science/engineering program.</li><li>Passing Sills Assessment Test.</li></ul>Experience:<ul><li>NECESSARY: Individual must successfully demonstrate and maintain proficiency in aseptic techniques and aseptic gowning by passing monitoring testing. Individual must continue to progress towards attaining a Level 2 position by completing training on required skills.</li><li>DESIRABLE: Previous laboratory or manufacturing operations experience requiring aseptic or sterile technique. Previous experience working in a GMP facility. Previous automated system or computer experience preferable.</li></ul>Equipment or machinery operated:<ul><li>Automated systems such as Distributed Control System (DCS) an automated process control system that governs the operation of most equipment. POMS, LIMS and IMPACT.</li><li>Analytical, monitoring, and laboratory/manufacturing equipment, including but not limited to: centrifuge equipment, spectrophotometers, pH and conductivity meters, scales, balances, filtration equipment, chromatography columns, off-gas analyzer, pumps and sampling assemblies, refrigerators, and CTUs.</li><li>Process vessels such as fixed and portable tanks, fermentors, bags and bottles.</li><li>Safety: personal protective equipment such as respirators, hearing protection, and other personal protective clothing. Biosafety cabinets and chemical fume hoods.</li><li>Material handling equipment such as drum lift, hand jacks, carts, hoists and pumps.</li><li>Decontamination and cleaning equipment such as autoclaves, disinfectants and mops.</li></ul>Special Skills or Abilities:<ul><li>Ability to perform aseptic/sterile operations. Mechanical aptitude and ability to analyze equipment and take appropriate corrective action.</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 2nd - Evening, 3rd - Night Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/30/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/30/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296627

Biotechnician Level 1/2

Job Description Duties and Responsibilities (including but not limited to): <ul><li>Helps to train new personnel</li><li>Ensures compliance with Generally Accepted Accounting Procedures, Sarbanes Oxley Act, internal and external accounting guidance and our company's standard operating procedures.</li><li>Responsible for the creation of Grants in our Grant Management System or Purchase Orders in SAP for Consultant or Vendor Agreements and maintaining all purchase orders or grants</li><li>Responsible for the creation of PPR payments in SAP for Ex-US consultant payments</li><li>Processing, tracking and approving monthly invoices in our Grant Management System</li><li>Reconciling grants or purchase orders</li><li>Resolving invoice issues for the vendors and consultants</li><li>Consulting with Global Clinical Trial Operations, Finance and Procurement on vendor or consultant contracts</li><li>Summarize Purchase Order/ Agreement justification for our Research & Development Division's Senior Management</li><li>Corporate Audit Support</li><li>Assures our company's Grant of Authority policies are followed</li></ul> Qualifications, Skills & Experience: <ul><li>High School degree required</li><li>Bachelor's degree preferred</li><li>3+ years in Accounting/Finance related position</li><li>Must have SAP experience</li><li>Excellent written and oral communication skills</li><li>Strong interpersonal skills</li><li>Knowledge of Microsoft Office applications especially Excel</li><li>Good interpersonal skills demonstrated as energetic, proactive, enthusiastic, and independent thinker</li><li>Excellent organizational and analytical skills</li><li>Ability to handle multiple priorities within matrix environment</li><li>Works and meets deadlines with minimal supervision</li><li>Demonstrated effectiveness working independently, collaboratively with peers and in cross-functional teams</li></ul>MSJR #EligibleforERP NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $68,400.00 - $107,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Remote Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 05/28/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/28/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295289

Payment Coordinator (Remote)

Job Description The Clinical Specialist position is a combined position of clinical scientist and study management duties supporting one or more clinical trials. Under the oversight of a clinical scientist, study manager, or program lead, the Clinical Specialist may be responsible for but not limited to: Job Responsibilities<ul><li>Maintain clinical trial files (including eTMF), project processes, tracking systems, and other utilized study or departmental systems</li><li>Generating and reviewing medical monitoring reports</li><li>Creating and maintaining project schedules</li><li>Distributing, reconciling, and archiving clinical documents</li><li>Tracking and reconciling labs/sam es</li><li>May interact with internal and external stakeholders (e.g., study sites, committees) in support of clinical trial objectives</li></ul>Core Skills<ul><li>Pharmaceutical, research, medical, and/or clinical drug development knowledge/experience</li><li>Strong communication, writing, and presentation skills</li><li>Effective time management and organizational skills</li><li>Ability to effectively work in a team environment and independently</li><li>Proficient knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)</li><li>Preferred: knowledge of GCP, project management, process improvement, data analytics</li></ul>Education/Experience<ul><li>Bachelor's Degree +1 years of pharmaceutical, clinical drug development, project management, and/or medical field experience</li><li>OR Master's Degree Degree in life sciences, preferred.</li></ul>NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. MRLGCTO CSSMHiring CSSMGenMed #eligibleforerp Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $68,400.00 - $107,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/25/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/25/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295750

Associate Scientist, Clinical Specialist

Job Description Position Description: Technician, Operations The Operations Technician position is available at our Animal Health facility in Elkhorn, Nebraska, located on the West end of Omaha. The Elkhorn facility is expanding operations to manufacture animal vaccines and biologics. Looking for talented individuals to join our Production teams using key technologies for cell culture, blending, filling and packaging. The Operations Technician is accountable for critical laboratory procedures and duties in the production of veterinary products. Technicians work with a variety of technical equipment while completing duties involved in blending, filling vials or packaging finished products for distribution. At all times technicians must follow Good Manufacturing Practices and Standard Operating Procedures (SOP) and adhere to all safety and company policies while performing assigned duties. Some of the duties may include, but are not limited to:<ul><li>Comprehend and follow Standard Operating Procedures (SOP) and Outlines of Production. </li><li>Comprehend and comply with cGMP guidelines and complete and review documentation for accuracy and completeness.</li><li>Prepare media and perform necessary cleaning/disinfecting of equipment and laboratories. </li><li>Work in a clean, aseptic environment (clean room environment). </li><li>Operate lab equipment including pumps, centrifuges, roller racks and miscellaneous instruments.</li><li>Clean, wrap, and sterilize laboratory equipment.</li><li>Assist in antigen processing or serial batching equipment set up, sterilization, and operation.</li><li>Perform aseptic procedures during antigen processing or serial batching operations.</li><li>Operate automated packaging line, fill machines, capping machines, freeze dryers, autoclaves, dry heat ovens, etc. in accordance with standard operating procedures.</li><li>Maintain concurrent records including manufacturing directions, log sheets, and all other pertinent documents.</li><li>Assist in monitoring and requisitioning laboratory supplies.</li></ul> Hours for the position are Monday - Thursday 5AM - 3:30PM. Position Qualifications: Education Minimum Requirement: <ul><li>High School diploma or equivalent; College degree in a relevant scientific field (biology / chemistry, life science) preferred.</li></ul> Required Experience and Skills: <ul><li>Strong verbal and written communication skills</li><li>Basic Math aptitude</li><li>Strong work ethic</li><li>Ability to lift 50lbs on an intermittent basis</li><li>Attention to detail</li><li>Ability to follow approved documentation practices</li><li>1-2 years relevant experience working in a production laboratory</li><li>Ability to work in a team environment</li><li>Basic computer skills (Word/Outlook/Excel)</li><li>Ability to follow Good Manufacturing Practices and Standard Operating Procedures</li></ul> Preferred Experience and Skills: <ul><li>2-3 years relevant manufacturing experience and a basic understanding of manufacturing procedures, techniques and equipment</li><li>Working knowledge of current cGMP and inventory control concepts (strongly preferred).</li><li>Knowledge of aseptic techniques and procedures.</li><li>Experience in large scale bacterial antigen processing and serial batching.</li><li>Experience using SAP&reg;</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Residents of Colorado Click here to request this role's pay range. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/4/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/04/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296205

Technician, Operations

Job Requirements We are excited to be a sponsor of SkillBridge and proud to offer transitioning service members a unique opportunity to gain valuable professional experience with our Company. With our generous military-friendly policies, we've received accolades from several organizations such as GI Jobs, Military Times EDGE, and Employer Support of the Guard and Reserve (ESGR). Consider a future with us and discover an employer who will foster your best work as you continue to strive for the well-being of others. Who we are ... We are known as Merck & Co., Inc., in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for ... Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your integrity, knowledge, imagination, skill, and teamwork to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today. Overview: Pharmacy Vaccine Account Representative SkillBridge Intern Description: Our Hybrid Sales team support our customers by providing clinical information about products, educational information, clinical training programs and resources. We support healthcare providers and healthcare systems in meeting the healthcare goals of the patients in their communities. The Pharmacy Vaccine Account Representative SkillBridge Intern (PVARSI) is a member of the Vaccine Account Team and supports the Company's Vaccines customer engagement model. The first portion of the SkillBridge Internship, the PVARSI will be trained to our company's standard of excellence in sales. Following upskilling and job training, the PVARSI will be responsible for engaging with assigned customers (i.e., pharmacy, medical groups, physician offices) in a way that supports the local market and focuses on population health and centers on the highest potential business opportunities with these customers that will improve our impact on public health. They will work with the local market team to understand and identify customer needs, proactively align products and services, support pull-through activities relative to integrated strategies, and ensure that our Company is viewed as demonstrating value and better health outcomes to healthcare professionals and their patients. The PVARSI is responsible for ensuring all activities adhere to the spirit and letter of all Company Policies and US Laws and Regulations. The PVARSI reports to the Customer Team Leader (CTL), Vaccine Customer Center, and works in close collaboration with broader Vaccine Field Sales team. <ul><li>This position is a hybrid sales position with 70% of the engagements with HCPs occurring remotely </li><li>The hours for the internship are 8 hours per day between 8AM - 7PM EST, Monday - Friday, adjusting hours aligned to the geographical time zone based on residence.</li><li>Our Team provides vaccine information and support to customers across time zones, as a result job hours vary depending on territory assignments. </li></ul>Position Responsibilities: Account Management & Contracting <ul><li>Understand multiple interdependencies within an account, consider customer healthcare goals and needs, and maximize account performance by building long-term relationships through collaborative business planning processes and approaches. This includes conducting customer business reviews with appropriate stakeholders discussing the financial impact of contracts and progress/ results of targeted vaccine programs and previously identified opportunities to improve customer benefits. </li><li>Maintain complete knowledge and understanding of our company's contract terms and conditions. Apply knowledge of contracts and historical ordering patterns to optimize vaccine purchases for customers and appropriate inventory in support of office protocols, vaccination goals, and seasonality in patient origination. </li><li>Establish and track account performance metrics to evaluate progress and performance, and to assess opportunity and need to adjust plans and associated tasks. </li><li>Apply knowledge of full portfolio of our company's vaccines, competitive brands, immunization recommendations and protocols to support the integration of a standard of care and the development and establishment of vaccination protocols. </li><li>Manage customer supply, product transition, and back-order challenges and communications. </li></ul>Sales Acumen <ul><li>Build trust with customers and demonstrate value in selling situations to deliver high-quality engagements or interactions that deliver products/ solutions with the common goal of improving health outcomes in pediatric, adolescent, and adult populations and across diverse customer segments. Work cross functionally with each Field Sales counterpart to provide support and resources that assist customers in achieving health outcomes. </li><li>Collaborate with customers through solid relationship management skills and leverage customer insights to provide appropriate information and solutions. </li><li>Change customer behaviors by understanding beliefs and experiences and providing appropriate insight that creates a different experience. </li><li>Create a compelling and logical rationale for the value of Company Vaccines (clinical) and Commercial Offers in support of patient health & wellness. </li><li>Ask strategic, insightful questions to obtain information on customer healthcare needs, use the insights to position Company vaccines and commercial offers. </li></ul>Customer Segmentation & Targeting <ul><li>Divide assigned customer population into groups of individuals who share similar characteristics and buying behaviors, and apply this information to focus on groups effectively, allocate promotional resources, and drive execution of commercial plans. </li><li>Evaluate and prioritize business across assigned customer segments. </li><li>Apply customer insights to effectively and differentially allocate marketing and field resources that drive execution of sales and marketing plans. </li><li>Communicate our Company's Vaccine clinical information and Commercial Offers in a way that is meaningful and relevant to each individual customer; customize discussions and client interactions based on understanding of customer's needs. </li></ul>Work Experience Requirement: Transitioning Service Member who is eligible for participation in the DOD SkillBridge program. Position Qualifications: Education: <ul><li>S1 - Bachelor's degree with 0-3 years Sales experience OR a minimum of high school diploma with at least 4 years of relevant work experience which could include: professional sales, experience in marketing, military, or healthcare/scientific field (pharmaceutical, biotech, or medical devices). </li><li>S2 - Bachelor's degree with 3 (36 months) or more years Sales experience OR a minimum of high school diploma with at least 6 years of equivalent experience which could include professional sales, experience in marketing, military or healthcare/scientific field that is not sales related (pharmaceutical, biotech, or medical devices). </li></ul>Preferred Experience and Skills: <ul><li>Primary Work Site/Schedule: Mon-Fri (first shift) </li></ul>Requisition ID:P-100826

Pharmacy Vaccine Account Representative - Military Skillbridge Opportunity (Remote)

Job Description Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Our company's Animal Health (AH) Division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and planet. This team of energetic, independent thinkers offers one of the industry's most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally. Our company's Animal Health, Elkhorn, NE is a BioTechnology Center of Excellence that manufactures, fills, packages and distributes vaccines for animals. As a member of the Regulatory Affairs Biologics team, the Senior Specialist is responsible but is not limited to the following duties:<ul><li>Provide USDA regulatory guidance and regulatory strategy with interdepartmental teams for pre and post license of US Biologicals.</li><li>Review, prepare and communicate regulatory submissions in support of new licenses or licensed biologicals with the USDA. Alternatively, may review and prepare registration documents for export markets.</li><li>Review market advertising and promotions for US biologicals in compliance with USDA regulations.</li><li>Prepare and maintain regulatory documents and communications regarding US biological products with local and federal agencies.</li></ul>Education: Minimum Requirements<ul><li>Bachelor's degree with at least 5 years of USDA or FDA regulatory experience, -OR - Master's degree with a minimum of 3 years of USDA or FDA regulatory experience in the vaccine or pharmaceutical industry.</li><li>Knowledge of USDA requirements and regulations relating to manufacturing and research and development of biological vaccines. Excellent time and project management skills. Excellent people, communication and leadership skills for involvement with cross departmental teams.</li></ul>#EBRG NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): n/a Job Posting End Date: 06/12/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/12/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R292516

Sr. Specialist, Regulatory Affairs

Job Description Biologics Process R&D Scientist Our Research Scientists are our Inventors. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we partner to deliver the next medical breakthrough. Biologics Process Research & Development (BPR&D) within our company's Research Laboratories is on a mission to rapidly deliver diverse biotherapeutics to patients by efficiently developing innovative, robust manufacturing processes and technologies. To achieve this, we work closely with colleagues in Discovery, Pre-clinical, Early Development, Analytical, Formulation, and Commercial Manufacturing while providing a diverse and inclusive environment for all. Beyond process development for pipeline biologics, we innovate and build next generation biomanufacturing technologies. Examples include investments for development of continuous manufacturing, green and sustainable processes, and proprietary technology platforms. We actively publish and engage with the scientific community to influence the field. BPR&D includes three lab-facing technical functional areas: Process Cell Sciences (PCS), Upstream Process Development (UPD) and Downstream Process Development & Engineering (DPDE). This job posting covers opportunities for all three functional areas. We are actively looking for highly motivated people with a passion for innovation and interest in contributing to one or more of the three technical functional areas mentioned above. As a Scientist in BPR&D, you will work with immensely creative and collaborative team members to design and develop robust processes in support of early- and late-stage biologics. You will innovate to support our company's biologics pipeline and production platforms through rigorous scientific principles. You will have the opportunity to apply and integrate innovation into biologic process sciences to establish our company as the industry leader in next-generation biologics manufacturing. You may also be expected to contribute to additional areas of interest such as biophysical, reactor, process, economic and/or multivariate modeling as we are committed to leveraging digital ways of working to enhance our ability to design robust processes. Responsibilities include but are not limited to:<ul><li>Develop innovative and disruptive technologies for next-generation biologics manufacturing processes</li><li>Develop and characterize robust clinical processes capable of delivering multi-kilogram quantities of therapeutics</li><li>Design and conduct experiments related to cell-line development, upstream or downstream bioprocessing</li><li>Integrate unit operations with relevant process control and monitoring platforms</li><li>Collaborate across BPR&D, process analytics, and other functional areas in research and manufacturing to advance the biologics pipeline</li><li>Conduct laboratory- and/or pilot-scale studies to support scale-up and technology transfer to manufacturing sites</li><li>Contribute to a safe and compliant laboratory work environment</li></ul> Minimum education required: BS with 2+ years of relevant experience or MS degree (expected graduation by December 2024) in Chemical/Biochemical/Biomedical Engineering, Biotechnology, Biochemistry, Molecular Biology, or related fields with research background in molecular biology, cell culture or protein purification Required experience and skills: <ul><li>Experience with one or more of molecular biology, protein expression, mammalian cell culture, protein purification, biochemical engineering, or analytical technologies</li><li> Scientific understanding of the engineering principles behind recombinant protein production and purification </li><li>Ability to comprehend and execute experiments independently</li><li>Ability to organize, communicate, analyze, and present experimental data to drive conclusions and further study designs</li><li> Knowledge of aseptic technique, protein biophysical properties, and general protein laboratory practices </li><li>Demonstrated ability to independently prepare technical documents and scientific presentations to capture development progress, scientific investigations, and technology development output</li><li>Basic understanding of statistical methods and data analysis tools</li><li> Strong passion and commitment to integrate science and innovation into biologic process development </li><li>Ability to excel in a collaborative and matrix environment</li></ul> Preferred experience and skills :<ul><li>Demonstrated capabilities in understanding and operating bioanalytical techniques to characterize microbial or cell culture processes</li><li>Ability to think critically with excellent problem solving and troubleshooting skills</li><li>High throughput screening, automated bioreactor systems, and liquid handlers</li><li>Experience with process transfer to clinical or commercial manufacturing facilities</li><li>Knowledge of process control and workflow automation tools</li><li> Strong foundation in statistical analysis, design of experiments, data science, computational modeling </li></ul>#BPRD #PRD #EligibleforERP #EBRG #vetjobs NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $83,100.00 - $130,900.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 06/5/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/05/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296125

Scientist, Biologics Process Research & Development

Job Description With support of Sr CRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.<ul><li>Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.</li><li>Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. </li><li>Gains an in-depth understanding of the study protocol and related procedures.</li><li>Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.</li><li>Participates & provides inputs on site selection and validation activities.</li><li>Performs remote and on-site monitoring & oversight activities using various tools to ensure:</li></ul>o Data generated at site are complete, accurate and unbiased o Subjects' right, safety and well-being are protected<ul><li>Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. </li><li>Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.</li><li>Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.</li><li>Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed. </li><li>Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites</li><li>Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.</li><li>Supports audit/inspection activities as needed.</li><li>Performs co-monitoring where appropriate.</li></ul>Extent of Travel Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling 2-3 days/week. Current driver's license preferred. Qualifications, Skills & Experience: Competency Expectations: <ul><li>Fluent in Local Languages and English (verbal and written) and excellent </li><li>Communication skills, including the ability to understand technical information. Developing ability to present technical information with support.</li><li>Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. </li><li>Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines. </li><li>Hands on knowledge of Good Documentation Practices </li><li>Developing skills in Site Management including management of site performance and patient recruitment</li><li>Developing level of monitoring skill and independent professional judgment.</li><li>Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.</li><li>Works with high quality and compliance mindset.</li><li>Capable of managing complex issues, solution-oriented approach.</li><li>Ability to perform root cause analysis and implement preventative and corrective action.</li></ul> Behavioral Competency Expectations: <ul><li>Effective time management, organizational and interpersonal skills, conflict management</li><li>Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.</li><li>High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.</li><li>Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.</li><li>Demonstrates commitment to Customer focus.</li><li>Positive mindset, growth mindset, capable of working independently and being self-driven.</li><li>Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.</li></ul> Minimum education required: B.A./B.S. required with strong emphasis in science and/or biology. Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar. #MRLGCTO #eligibleforERP #ETJOBS NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $75,400.00 - $118,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 50% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): n/a Job Posting End Date: 05/28/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/28/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295712

Associate Clinical Research Associate -Louisiana, Arkansas, New Mexico and Oklahoma(REMOTE)

Job Description We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director. The team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration. Associate Directors are emerging leaders in the field of quantitative drug development, with a developing understanding of the strategic elements of drug development and effective communication skills. As a subject matter expert, the Associate Director within the Group will work closely with teams of highly collaborative, cross-functional scientists to contribute to development of novel chemical entities. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. They collaborate with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact strategies and decisions on drug development teams. Primary Responsibilities: <ul><li>Serving as an expert representative for on Oncology clinical development teams.</li><li>Framing critical questions for optimizing model-based analyses on programs.</li><li>Developing and executing model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, comparator modeling, thereby strengthening pharmacometrics capabilities on a continuous basis in decision making and driving pipeline impact.</li><li>Strategizing and executing modeling of tumor size and survival endpoints including proportional hazards models.</li><li>Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing our team at regulatory meetings. </li></ul> Education Minimum Requirement: <ul><li>Ph.D. with 1-3 years of pharmaceutical drug development experience relating to: PKPD, pharmacometrics, mathematics, statistics/ biostatistics, or chemical/biomedical engineering.</li><li>Masters or PharmD, with 3-5 years of experience, where experience" means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development.</li></ul> Required Experience and Skills: <ul><li>Demonstrated impactful experience with applications of pharmacometrics methods.</li><li>Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.</li><li>Proficiency in R, NONMEM or other similar programing language.</li><li>Professional working proficiency in written and verbal communication.</li></ul>EBRG# NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $149,400.00 - $235,100.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Required Skills: Business Intelligence (BI), Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management, Software Development, Stakeholder Relationship Management Preferred Skills: Job Posting End Date: 07/6/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:07/06/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295551

Associate Director, Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (Hybrid)

Job Description Our company's Information Technology (IT) division partners with colleagues across the business to help serve our patients and customers around the world. Ours is a high-energy team of dynamic, innovative individuals dedicated to leveraging information and technology to efficiently drive revenue and productivity, thereby advancing our company's contribution to global medical innovation. Enterprise IT (EIT) is an essential component of the current IT division that provides support to the Pharmaceutical Research and Development (R&D), Supply Chain (Manufacturing), Marketing (Human Health) organizations as well as Enabling Functions. The EIT SAP Platform Team is responsible for our company's SAP Global Template asset, delivering enterprise-level capabilities through harmonized business processes and data. The team is responsible for the operation of all our company's SAP and integrated solutions, governance of the associated enterprise assets, and cost-effective delivery of capabilities to support achievement of immediate and future state business objectives. Within the EIT SAP Platform Team, the Financial and Budgeting lead will have responsibility to track and manage TCO (Total Cost of Ownership) for the SAP Platform Value Team. This includes managing the portfolio processes from leading the preparation of the business case to tracking financials related to project execution and closeout. The incumbent will also lead the contracting/PO process for goods (software/product licenses) and services procurement, including tracking and reporting on actuals through metrics and dashboards. The ideal candidate will have a good understanding of IT financial planning and management processes and the ability to connect requirements from different groups through excellent communication, facilitation, negotiation and influencing skills. Responsibilities to Include: <ul><li>Managing the end-to-end portfolio governance process from budget preparation and funding, to tracking/reporting actuals, asset creation and closure</li><li>Developing and executing a process to develop standardized budgets for business cases and take them through funding approval and set-up for execution</li><li>Manage PO creation, forecasting and invoice processing/approvals in partnership with PO owners for all external POs in support of SAP Platform initiatives and operations.</li><li>Managing collection and tracking process for resources (internal and external) and appropriate allocation to initiatives</li><li>Understand licensing terms for each product and work with product owners and SMEs to actively track and report usage trends.</li><li>Execute IT financial planning and forecasting processes and manage updates to systems of record.</li><li>Ensuring data consistency and accurate mapping across various trackers and systems of record - ie product model mapping for the SAP platform value team in iServer, Apptio for tracking TCO and other standard financial tools</li><li>Ad-hoc initiatives to support operational financial management of the platform budget and forecast</li><li>Strong partnership and alignment with EIT Finance and IT PMO</li><li>Ensure compliance with IT financial controls and standards</li></ul> Qualifications, Skills & Experience: The ideal candidate will have strong analytical skills to conduct ad-hoc analysis and provide insights to support proactive planning of portfolio, operational budget and contract reviews, approvals and renewals. The incumbent will be responsible for ensuring the consistency, quality, reliability, efficiency of the information used to make financial decisions related to portfolio, resource planning, financial operations, licensing and contracting for the EIT SAP Platform. The incumbent will be responsible for leading a team of our company and partner resources to effectively work in a highly matrixed environment while managing multiple and competing priorities. Education Level:<ul><li>Bachelors Degree required.</li></ul>Required Experience:<ul><li>Minimum of 5 years of relevant work experience.</li><li>Proven work experience managing financials around portfolio and operations required.</li><li>Excellent communication (written and oral) and interpersonal skills to effectively collaborate with cross-functional teams and stakeholders required.</li><li>Experience with governance processes around portfolio business case preparation and approvals required.</li><li>Understanding of software licensing and services contracting terms and conditions for large scale IT operations in a SAP or similar ecosystem required.</li><li>Working knowledge of common tools used in this role - MS-Project, Spotfire, PowerBI, SharePoint and MS Office tools (Word, Excel, PowerPoint) required.</li><li>Strong problem-solving and analytical abilities, with acute attention to detail required.</li><li>Project management skills, including the ability to prioritize tasks, meet deadlines, and coordinate resources required.</li><li>Continuous improvement mindset: always seeking opportunities to enhance processes, streamline operations, and improve the accuracy of the financial data required.</li><li>Proven ability to effectively work in a highly matrixed environment, with partners from different internal and external groups and time zones required.</li><li>Ability to manage multiple and competing priorities required.</li><li>Excellent skills in leveraging metrics and data for dashboards and presentations required.</li></ul>Preferred Experience:<ul><li>Knowledge of various SAP ERP modules, and experience with licensing for ECC, S/4 HANA and cloud platforms, etc. preferred.</li><li>Atlassian tools (Jira & Confluence) and Planning tools such as Apptio for financial planning and TCO management (Total Cost of Ownership) preferred</li><li>Knowledge of Pharmaceutical industry and validated software environments preferred</li></ul>#eligibleforerp NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $122,800.00 - $193,300.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/4/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/04/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294963

Associate Director, SAP Finance & Budgeting Lead (Hybrid - NJ or PA)

Job Description<ul><li> Job Description In Primary Posting Language </li></ul> Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Position Description This is a day /night shift position, 12.5 hour ( 6:00 AM - 6:30 PM/6:00PM - 6:30 AM ) rotation (2-2-3). The Vaccine Manufacturing Facility Production Associate is an excellent opportunity for experienced individuals that are interested in working in vaccine production and manufacturing operations. The individual in this position will support the vaccine manufacturing process through hands on processing activities. Key responsibilities for the Production Associate include the execution of aseptic processing requirements, adherence to Good Manufacturing Practices, and working in a self-directed team environment to accomplish shift and departmental goals. Responsibilities include, but are not limited to: <ul><li> Works collaboratively with all operations and support personnel, performing manual and automated processing of vaccine manufacturing equipment, performing general troubleshooting tasks, and supporting functions necessary for the production of vaccines. </li><li> Executes all documentation and clerical functions necessary for proper accountability and trace-ability of product. </li><li> Maintains, inventories, and transports all required processing equipment, materials, supplies and products needed to support manufacturing. </li><li> Operates various computer-controlled process support/process equipment ( i.e. washer, autoclave, vial filler, lyophilizer , capping/inspect machines, etc.). </li><li> Assists in troubleshooting of equipment. </li><li> Performs housekeeping in all work areas. Executes facility sanitization and decontamination according to approved procedures. </li><li> Completes in-process testing and inspections supporting the vaccine manufacturing, validation, and development processes as required . </li><li> Identifies and addresses compliance, environmental, safety, and process deviations as appropriate and escalates to appropriate personnel . </li></ul><ul><li> Maintains, cleans and prepares equipment used in vaccine manufacturing process. </li><li> Schedules and performs environmental monitoring during processing and records results in the computerized database system. Provides timely delivery of sample and other materials as required to appropriate laboratories, coordinating with Quality and Logistics as required . </li><li> Attends and actively participates in safety & housekeeping, walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required . </li><li> Serves on safety, quality and other committees as required . </li></ul> Education Minimum Requirement: <ul><li> High School Diploma or equivalent is required for this position. Prefer Bachelor's degree in Life Science or Engineering or Associate's degree in Life Science or Engineering with at least 2 years relevant experience </li></ul> Required Experience and Skills: <ul><li> Must be willing to work 12-hour day/night shift ( 6:00 A M to 6:30 P M /6:00PM to 630AM ) on a rotating 2-2-3 schedule. Note that this schedule does include working alternating weekends and holidays </li><li> Must be able to successfully pass Aseptic gowning qualification. Aseptic gowning requires that all skin and hair be covered through wearing the following: Beard/mustache cover, hair net, hood and face mask, goggles, jumpsuit, gloves and boots. </li><li> Must be willing and able to lift 50 lbs </li><li> Must be willing to work various shifts </li><li> Must be able to demonstrate basic computer literacy (internet browsers, e-mail, word processing). </li></ul> Preferred Experience and Skills: <ul><li> Bachelor's degree in Life Science or Engineering </li><li> Associate's degree in Life Science or Engineering </li><li> BioWorks Certificate (working in an FDA regulated industry). </li><li> Experience utilizing System Applications and Products in a manufacturing setting. </li></ul><ul><li> Experience in the use of Electronic Batch Records </li><li> Experience performing Environmental Monitoring and Sampling a</li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE Secondary Language(s) Job Description US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscriminatio n We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 06/5/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/05/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295929

Job Description Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. Looking for someone with a growth mindset. The Director, Regulatory Affairs Liaison is responsible for:<ul><li>Developing regulatory strategy for their assigned products, in order to optimize label and obtain shortest time to approval by regulatory agencies.</li><li>Independently manages projects within the General Medicine Therapeutic Area, functioning as the single, accountable, global point of contact on those projects.</li><li>Functions as first liaison assigned to programs where the compound is first-in-class or is in a new therapeutic area for our company; where no regulatory guidance exists; where the program is extremely accelerated; is an Alliance program; there are multiple indications, the filing is global and/or it is a new disease target with no official regulatory guidance.</li><li>Independently interacts with worldwide regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more our company's investigational and marketed drugs.</li><li>Programs may be complex with more than one indication, formulation or have an external business partner.</li><li>Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions.</li><li>Responsible for regulatory review and final approval of all submissions and associated documentation.</li><li>Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.</li></ul>Primary activities include, but are not limited to:<ul><li>Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.</li><li>Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.</li><li>Provide leadership to the staff by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.</li><li>Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.</li><li>Represents our company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chair meetings between company and FDA; prepare our company's teams for meetings with FDA at any phase of drug development. Lead cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.</li><li>Coordinate interactions with foreign agencies through Regulatory Affairs Europe (RAE), Regulatory Affairs International (RAI), and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously. </li><li>Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before release from our company to external agencies and investigators.</li><li>Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.</li><li>Represent GRACS within our company's internal committees to provide regulatory advice and approval according to the committee charters. (Therapeutic area document review committees (DRC), Global Regulatory Team (GRT) Product Development Team (PDT), Early Development Team (EDT), and Labeling Working Groups). </li><li>Participate in regulatory due diligence activities for licensing candidate review. </li></ul> Minimum Education & Experience Requirements: <ul><li>Degree in biological science or related discipline</li><li>B.S., with minimum of 7 years of relevant drug development experience</li><li>M.S. with minimum of 7 years relevant drug development experience</li><li>M.D. with minimum of 3 years relevant drug development experience or clinical experience</li><li>PhD/PharmD with minimum of 5 years relevant drug development experience</li></ul> Required Experience: <ul><li>Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead.</li></ul> Preferred Experience: <ul><li>Small and large molecule experience</li><li>Substantial experience in Regulatory Affairs</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. GRACSJOBS #EBRG #VETJOBS Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $164,800.00 - $259,400.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): na Job Posting End Date: 06/21/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/21/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295934

Director Regulatory Affairs Liaison- General Medicine (Hybrid)

Job Description Job Description: Our Digital Manufacturing Operations Team supporting our vibrant West Point site is seeking a Process Automation Engineer Associate to join our team. This role will provide automation system support and expertise to enable our manufacturing division in the reliable and compliant supply of quality vaccine products to customers and patients across the globe. Responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations. Actively support, participate and embrace a diverse and inclusive culture including significant interaction with manufacturing, quality and engineering groups. Supports a broad spectrum of automated systems within GMP Manufacturing Operations. Key Functions <ul><li>Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion</li><li>Comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.</li><li>Provide automation system support and expertise to assist the manufacture of quality vaccine products to meet site priorities.</li><li>Responsible and accountable for supporting all automation system components of the processes including on the shop floor support of manufacturing activities</li><li>Responsible for designing, implementing, testing, and closing-out change controls for automation related corrective actions and continuous improvement initiatives.</li><li>Build relationships with functional counterparts and stakeholders in the business to proactively. identify and resolve technical issues.</li><li>Lead or participate in investigations of automation incidents and problems to prevent recurrence including the development and implementation of corrective actions.</li><li>Stay current with latest automation technologies and trends and make recommendations for adoption</li><li>Provide off-site weekend/evening automation phone or on-site support for our 24/7 manufacturing operations.</li></ul> Education: <ul><li>High school diploma and four (4)+ years demonstrated experience in process automation -OR-</li><li>Bachelor degree in Engineering (Computer Science, Electrical, Chemical or Mechanical)</li></ul> Experience | Skills | Knowledge: Required <ul><li>Strong verbal and written communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external parties.</li></ul> Preferred <ul><li> Familiarly with Computer system validation and regulatory GXP requirements </li><li> Technical and operational expertise in the following disciplines DeltaV, DCS, PLC, SCADA, HMI, network infrastructure, SQL, etc. </li><li> Knowledgeable of S88 Batch Standard </li><li>Experience in pharmaceutical/ biotechnology industry.</li><li>Knowledge and/or experience in process control</li><li>Aseptic processing/sterile manufacturing experience. </li><li>Technical and operational experiences in computer systems and programming</li></ul>MSJR NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 06/4/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/04/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R293501

Associate Specialist, Manufacturing Automation

Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! As a member of the Engineering Maintenance & Utilities (EMU) Reliability Engineering Group, the primary role of the Reliability Engineer is to support the development, implementation and sustainment of a dedicated Reliability Plan to improve the process and utility asset reliability within a department, integrated process team (IPT), or end-to-end (E2E) operating unit, as appropriate. This role will require significant skill in the areas of data analysis, selection and application of reliability tools, field execution, and close collaboration with other groups in order to achieve reliability performance targets. Through analysis of field conditions, operating history, performance data, and equipment capabilities, combined with their knowledge of reliability tools and computerized maintenance-management system (CMMS) application, the Reliability Engineer is responsible for maintaining, communicating and executing the Reliability Plan in order to reduce equipment risk & improve equipment availability. Successful execution of this process will require flexibility, field coordination and execution, effective communication with peers and leaders, and careful task management. Job technical responsibilities include, but are not limited to: <ul><li>Being a key member of an area reliability engineering team, including interfacing with team members, identifying and prioritizing reliability risks, understanding equipment downtime and availability related issues, selecting reliability tools to address risks, and communicating status of mitigating actions</li><li>Field application of Reliability tools and principles to ensure that equipment operates in compliance with safety, environmental, and quality requirements</li><li>Ability to adapt to and understand challenges of supported area and the ability to quickly learn and apply new reliability principles</li><li>Define, design, develop, monitor and refine the preventive/predictive maintenance processes and precision maintenance techniques</li><li>Perform root cause failure analysis on equipment failures and develop strategies to prevent recurrence</li><li>Serve as technical liaison for capital projects to ensure reliability, maintainability and operability of installed equipment</li><li>Monitor the performance of equipment reliability & calculate availability metrics, investigate variance from targets and implement action items to improve performance</li><li>Provide technical input to support production area quality deviation investigations</li><li>Conducting spare part reviews or maintenance reviews to ensure that CMMS data is properly configured to support reliability efforts (ensuring accurate asset bill of materials and effective maintenance plans)</li></ul> Job leadership responsibilities include, but are not limited to: <ul><li>Project management, including reliability enhancement task/project accountability (e.g. scoping, planning, scheduling) with a significant level of self-direction</li><li>Execute reliability enhancements to meet production targets and reduce maintenance costs</li><li>Influencing others to adopt different points of view as appropriate</li></ul> Education Minimum Requirement: <ul><li>Bachelor's degree in engineering or equivalent technical major</li></ul> Required Experience and Skills: <ul><li>Two (2) years' experience in a functional area such as Operations, Technology, Engineering, Maintenance, Military and/or previous supervisory experience</li><li>Two (2) years' expertise in industrial manufacturing, maintenance, or reliability engineering</li><li>Solid computer skills, including Microsoft Word, Excel, and PowerPoint</li><li>Strong mechanical aptitude</li><li>Strong communication and interpersonal skills</li></ul> Preferred Experience and Skills: <ul><li>Experience with equipment maintenance work in continuous flow processing or manufacturing is strongly desired</li><li>Certified Maintenance and Reliability Professional (CMRP) or Reliability Centered Maintenance (RCM) Certification</li><li>Spare Parts Management</li><li>Root Cause Analysis</li><li>Computerized Maintenance Management System (SAP or Infor EAM/HxGN)</li><li>Two (2) years' experience in supporting relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, utilities, etc.)</li><li>Demonstrated knowledge of High Performing Organization tools and methodology, including Lean Six Sigma Methodology (Green Belt certification)</li><li>Demonstrated experience of interacting with site, divisional, or regulatory audits</li><li>Working knowledge of cGMP for pharmaceutical and/or vaccine manufacturing</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. VETJOBS If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/4/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/04/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294185

Reliability Engineer

Job Description Duties and Responsibilities (including but not limited to):<ul><li>Ensure Sarbanes Oxley controls compliance is maintained throughout the grants generation, payment execution, financial close, and reporting processes throughout the Grants Management System (GMS).</li><li>Identify and resolve any system discrepancies.</li><li>Participates in internal and external audits and Sarbanes Oxley control testing.</li><li>Maintenance of all SOPs for all GMS procedures and provide guidance to our Research & Development Division Business partners involved in the grants process.</li><li>Partner with our Research & Development Division Finance and our Research & Development Division Business partners to develop and document process improvements and communicate any GMS process changes, enhancements, and training.</li><li>Review all GMS grant and payment requests for our company's managed clinical grants including all necessary documentation for policy compliance. Approve / reject requests as appropriate.</li><li>Completes footnote process and GMS/Spectrum accruals on a monthly basis.</li><li>Analyze and report required monthly of our Research & Development Division Physicians Payment Sunshine Act (PPSA) payment detail based on the Federal Sunshine Act requirements related to Transparency Reporting to our Research & Development Division Compliance.</li><li>Serve as our Research & Development Division Compliance Liaison and provide financial support, analysis and ad hoc reporting as required by our Research & Development Division Compliance.</li><li>Serve as a regional support contact providing daily issue resolution, training and communication regarding GMS related activities.</li></ul>Qualifications, Skills & Experience Minimum education required: <ul><li>High School degree required.</li><li>Bachelor's degree preferred.</li></ul> Required experience and skills: <ul><li>5+ years in Accounting/Finance related position.</li><li>Must have SAP experience.</li><li>Excellent written and oral communication skills.</li><li>Strong interpersonal skills.</li><li>Knowledge of Microsoft Office applications especially Excel</li><li>Good interpersonal skills demonstrated as energetic, proactive, enthusiastic, and independent thinker.</li><li>Excellent organizational and analytical skills</li><li>Ability to handle multiple priorities within matrix environment.</li><li>Works and meets deadlines with minimal supervision.</li></ul>MSJR #EligibleforERP NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $68,400.00 - $107,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Remote Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 05/28/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/28/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295286

Research Finance Processor (Remote)

Job Description Position Description: HVAC Operations Manager Reporting to the Associate Director in HVAC, the HVAC Operations Manager will be part of the 24-hour operations team for the site. The Manager will direct a team of hourly personnel who are accountable for the 24-hour operations of the site. The Manager is the first responder to all emergency calls who will investigate and initiate work orders to the appropriate technical trade shops. Actively aligns, participates and embraces our team culture including significant interaction with operations, safety, automation, and other groups as necessary. This Position sits in Rahway, NJ and is a 12-hour rotating shift. Position Duties: <ul><li>Compliance - Accountable for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Accountable for establishing a Safe by Choice. Accountable to review and approve compliance documents, as per procedures or need.</li><li>Continuous Improvement - partner with GWES engineering project improvement efforts. Identify opportunities to improve process efficiency, cycle time, and yield, reducing process variability, and eliminate waste.</li><li>Financial Stewardship - Accountable for meeting the Shift(s) operating budget and continuously reducing cost. Ensure members of the Shift(s) have business acumen and understand how they may impact business finances.</li><li>People Management - accountable for creating and sustaining a highly engaged workforce through utilization of our Company Leadership Behaviors and Inclusion. Provide coaching on professional development and career paths. Manage direct reports attendance, absenteeism, and vacation time to effectively support site operations.</li></ul> Primary assignments: <ul><li>HVAC/Refrigeration equipment, BAS (Building Automation Systems), -70 Freezers and 2-8C Cold rooms).</li><li>Support equipment (e.g., compressed gas piping systems, filtration systems, waste equalization/neutralization).</li><li>Process utility equipment (e.g., clean steam generators, water-for-injection generation/distribution, reverse osmosis skids, vapor compression stills).</li><li>Automated systems (e.g., distributed control system, programmable logic controllers).</li><li>Maintenance equipment (e.g., tools and calibration equipment).</li><li>Interact with vendors and support project coordination activities.</li><li>Actively promotes safety initiatives, including shop floor audits, lockout/tagout and Hazardous Energy Control Procedure updates.</li><li>Provides training to others, as necessary.</li><li>Completes written documentation of work performed.</li><li>Executes SAP transactions.</li><li>Ability to lift/move materials/equipment weighing up to 50 pounds.</li><li>Expected to work as part of a unified team to achieve site mission, vision, and goals through efficient and safe operation of equipment and compliance with Good Manufacturing Practice (GMP).</li><li>Ability to work flexible hours to accommodate special projects, shutdowns and/or maintenance activities.</li></ul> Position Qualifications : Education Minimum Requirement: <ul><li>Undergraduate in Business, Science, or Engineering with four years of relevant work history in manufacturing, site operations, or the military service. Or</li><li>HS Diploma/GED with six years of relevant work history in manufacturing, site operations, or military service.</li></ul> Required Experience and Skills <ul><li>Four (4) years of relevant work history in a functional area, such as Operations, Technical Operations, Technology, Engineering, Maintenance, Military and/or previous supervisory experience in industrial manufacturing.</li><li>Strong mechanical aptitude.</li><li>Four (4) HVAC/Refrigeration experience</li><li>Experience in a manufacturing or operations environment with duties including mechanical troubleshooting and repair of automated equipment.</li><li>SAP (or equivalent) related to plant maintenance and spare parts procurement systems.</li><li>Working knowledge of regulatory requirements in accordance with GMPs.</li><li>Ability to work in a highly effective team environment.</li><li>Strong communication (written/verbal) skills.</li><li>Ability to manage multiple priorities and time management skills.</li><li>Proficiency in computer systems and applications including but not limited to Microsoft Office (Word, Excel, Outlook, and PowerPoint), Programmable Logic Controllers.</li><li>Record of safely and effectively leading teams in an operations environment.</li><li>Consistent demonstration of strong leadership, communication, social, teamwork, technical, and problem-solving skills.</li><li>Self-starter desire to excel personally and ability to motivate direct reports and peers to excel.</li></ul>Preferred Experience and Skills:<ul><li>Minimum of (2) years with relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, utilities etc.).</li><li>Three (3) years of supervisory/management experience.</li><li>Demonstrated history of interacting with site, divisional or regulatory audits.</li><li>Strong communication (written/verbal), and multi-tasking abilities.</li><li>Ability to prioritize conflicting assignments in an operations environment.</li><li>Plant maintenance, instrumentation, project engineering and/or operations experience.</li><li>Experience interfacing with Computer Maintenance Management Systems SAP.</li><li>Working Knowledge of cGMP for pharmaceutical and/or vaccine manufacturing.</li></ul> Vetjobs gwesfin400 #eligableforerp MSJR GWES NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $101,100.00 - $159,100.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): n/a Job Posting End Date: 06/5/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/05/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294403

HVAC Operations Manager

Job Description The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of technical and project management responsibility. The Specialist -Engineering position will report to the Associate Director, Engineering and will be a member of the EF Team at the Rahway NJ facility. This position will be located in the Prep Lab facility which is responsible for interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new chemistries, and exploring new technologies. Responsibilities of the Specialist - Engineer include the following: The engineer role at the Specialist level is a member of the Prep Lab team and will be responsible for working directly with the Prep Lab staff to support scientific teams who are using the Prep Lab facility. This support involves training scientists new to the Prep Lab, reviewing procedures with the teams prior to processing, ensuring that the labs and equipment in the facility are ready for the GMP and non-GMP work that the scientists need to perform, working with the scientists to set up their equipment and ensuring that labs and equipment are clean and turned over after use. When the scientists encounter equipment and processing issues, the Specialist will be engaged in troubleshooting to find safe and compliant solutions to those issues in a timely manner. The Prep Lab is building a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) drug substance lab and the Specialist will become a subject matter expert for this lab, and also for the related smaller scale potent development lab in the facility. As the new lab is currently under construction, the selected candidate will contribute to equipment and facility design, commissioning/qualification, as well as other critical activity workstreams to enable lab startup. They will also become a subject matter expert for a Grade C lab in the facility. The selected candidate is expected to be a key part of the Prep Lab team and foster a culture of collaboration, learning and innovation. They will work closely with the development engineers & chemists, compliance representatives, safety partners and other team members to ensure the quality and safe delivery of clinical supplies, and ultimately to enable flexibility and speed in the execution of the Company's pipeline. This role may support facility operations, support compliance investigations/change management, author GMP documentation and manage/lead engineers in any of our enabling facilities. Additional Supported Areas: As required and in addition to support of the Prep Lab the Specialist may provide direct support to other areas such as: Small Scale Organics Pilot Plant (SSO): The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization. The pilot plant's mission is to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites. MACS : The Modality Agnostic Chemistry Scaleup (MACS) Center is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. Education Minimum Requirement: <ul><li>Bachelor's degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field with minimum of 3 years relevant experience, or a Master's degree with 1 year of relevant experience.</li></ul> Required Experience and Skills: <ul><li>Experience working in a GMP clinical or manufacturing supply facility.</li><li>Experience with small molecule drug substance and/or biologics process development.</li><li>Experience in supporting compliance investigations and change management.</li><li>Familiarity with US and EU GMP and Safety compliance regulations</li><li>Ability to prepare Standard Operating Procedures (SOP) and cGMP documents.</li><li>Effective interpersonal and communication skills, both verbal and written.</li><li>Excellent organizational skills to multi-task.</li><li>Desire and willingness to learn, contribute and lead.</li><li>Track-record of independent problem-solving.</li><li>Experience with coordinating maintenance activities around processing activities to support reliable facility operation.</li></ul> Desired Experience and Skills: <ul><li>Experience operating/maintaining pilot scale or prep lab (kg) scale equipment.</li><li>Experience providing technical mentorship.</li><li>Experience with Potent Compound processing and containment systems (e.g., isolators).</li><li>Experience with Quality systems</li></ul>NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. #EligibleforERP #vetjobs #EBRG Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $83,100.00 - $130,900.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 05/29/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/29/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294988

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