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About the Role The Manager, Quality Control Microbiology Technical Support, is responsible for providing technical support to QC and Manufacturing and managing a team to conduct investigations. Supports QC Microbiology in managing the transfer and technical oversight of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability). Establishes user requirements for purchase, qualification of QC equipment and work with internal and external resources to maintain equipment in an optimal state. Develops, revises and reviews SOPs, qualification/validation protocols and reports. Reviews and manages team to conduct investigations regarding out of specifications (OOS) results and EM excursions. Monitors the GMP systems currently in place to ensure compliance with documented policies. Manages Aseptic Gowning, Aseptic Techniques and Microbiology Training Gathers metric information for use in continuous improvement of areas of responsibility. Project management for QC related projects. Diversity & Inclusion / EEO We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:<ul> <li>Novartis: e-mail [email protected] or call +1 (877)395-2339</li><li>Sandoz: e-mail [email protected] or call: +1-609-422-4098</li></ul> Role Requirements Bachelor's degree or advanced degree in Microbiology or related discipline with 8 years' experience working in a GMP QC Microbiology and Environmental Monitoring laboratories, preferably in an aseptic processing facility. Ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs. Strong knowledge of Environmental Monitoring equipment, requirements and tests (viable and non-viable), Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals. Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/1271, ISO 14644-1, USP, EP). Extensive experience in conducting laboratory and environmental excursion investigations. Previous training experience. Ability to communicate and work independently with scientific/technical personnel and comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities. Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description. Ability to think critically and demonstrate troubleshooting and problem-solving skills. The pay range for this position at commencement of employment is expected to be between $112,800 and $169,200 annual; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

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Manager, QC Technical Support

About the Role Location: East Hanover, New Jersey, NYC, New York, or Basel, CH Hybrid #LI-Hybrid As the Global Program Head, Neuroscience, you will have critical impact of delivering innovation, which drives Novartis' mission to embark on a journey to reimagine medicine. In this role, you will lead programs through the end-to-end development cycle to seek successful registration and market access. This includes all medical and scientific aspects of clinical trials, programs and studies from the design phase, through implementation and finalization to include scientific and medical input into the final review and sign-off of all pertinent clinical trial. Your Key Responsibilities: &bull; Establish program strategy and execute implementation through milestones and decision points by leveraging cross-functional teams. &bull; Drives and implements short- and long-term project vision and strategy, while ensuring alignment across global functions, regions and CPOs in regard to strategy and direction. Communicate clear strategy to program team and functions and ensures that is reflected in the operation. &bull; Key contributor to development leadership team and influences direction of area of responsibility with long term approach. May be responsible for strategy at the disease area level encompassing multiple indications, spanning multiple products. &bull; Lead multidisciplinary team of functional experts focused on securing global regulatory approval, market access and optimized commercial value of the program, while ensuring quality, compliance (internal and external), within budget, and in a competitive and timely manner, utilizing both internal and external resources necessary. &bull; Leverage knowledge, experience, understanding of external stakeholders, internal team capabilities and portfolio needs to develop a compelling and innovative vision and strategy for the program. &bull; Deploys and prioritizes resources across development units. &bull; Ensures rigorous adherence to quality and compliance. &bull; Reports technical complaints, adverse events, special case scenarios related to products within established timelines and protocols. &bull; Drives talent acquisition among team members and within their sub-teams, including active selection and de-selection and performance management of the core membership of the program team. &bull; Expected travel: approximately 20% US domestic and/or international travel. Diversity & Inclusion / EEO We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:<ul> <li>Novartis: e-mail [email protected] or call +1 (877)395-2339</li><li>Sandoz: e-mail [email protected] or call: +1-609-422-4098</li></ul> Role Requirements Essential Requirements: &bull; PhD degree in the related discipline with 10+ years of drug development experience, including experience in Global Program Teams and with dossier submission for new or supplemental indication. &bull; Deep drug development experience in neuroscience or related disease area. &bull; Prior exposure to and strong awareness of regulatory / market access / commercialization requirements particularly for US. &bull; Clinical background relevant to the programs in the development franchise (medical training or experience in program teams). &bull; Experience in product registration and major health authority interactions. &bull; Longstanding experience of leading multidisciplinary teams. &bull; Innovative strategic attitude. Desirable Requirements: &bull; M.D. highly desirable. &bull; Clinical and or research experience in neurology/neuroscience, preferably neurodegeneration &bull; Strong external network in field of neuroscience. &bull; Strong publication record with expertise recognized in the field of neurodegeneration or other compelling credentials relevant to neuroscience drug development. &bull; Experience in using AI/digital in research and or development. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $298,400-$447,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Global Program Head, Neuroscience (Ph.D. or M.D.)

About the Role Allergy Territory Account Specialist - Syracuse, NY - Remote This is a field-based and remote opportunity. Novartis is more than an organization. It is a thriving community where talented people can truly belong. Working closely and collaboratively, we achieve a collective impact that is far greater than any of us could achieve alone. When we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for the world. Every advance we make, however large or small, helps to improve the lives of patients and their families. It inspires us to go further, always seeking 'better' for the people relying on us. The Territory Account Specialist is responsible for providing solutions to their customers by acting as the key orchestrator of Novartis resources and solutions for a variety of customers, including Health Care Providers, Reimbursement Personnel, Practice Administrators, Key Account, and Integrated Delivery Network partners and is accountable for working collaboratively to help ensure customer inquiries are solved by the appropriate Novartis Subject Matter Expert (SME). The Territory Account Specialist is well-versed in the following areas: Clinical Selling, Account Selling, Access Navigation, Problem Solving, Team Orchestration / Collaboration, and Omni-Channel Engagement. Key Responsibilities: &bull; Facilitate clinical dialogue that compels the customer to act on behalf of their patients and engage the entire account to understand any obstacles that exist to provide appropriate solutions to ensure customer needs are met. &bull; Identify shared priorities and leverage knowledge and tactics within the full account to develop a strategic territory business plan that drives product demand by meeting the needs of key partners and ultimately their patients to drive superior results. &bull; Orchestrate in a collaborative manner with territory colleagues, other field-based and home-office personnel teams to proactively address customer needs and provide appropriate access support. &bull; Apply expertise and knowledge of the marketplace, applicable competitors, industry, and cross-functional activities/plans to anticipate and optimally manage business opportunities/challenges. &bull; Analyze territory market data and trends to gain insights into the local business environment, drive pull-through and lead virtual and / or live engagements with customers. &bull; Lead any required planning meetings with key partners to solve more sophisticated customer problems and work collaboratively across functions to ensure customer needs are met with urgency. &bull; Provide appropriate access support in the moment and collaborate effectively with Patient Specialty Services (PSS) associates to meet customer needs. &bull; Understand how to leverage systems and omni-channel/multi-channel options to apply the full suite of Novartis capabilities to personalize and engage with customers in both face-to-face and virtual environments. Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected] . Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between: Territory Account Specialist: $102,400 and $153,000/year | Senior Territory Account Specialist: $124,000 and $186,000/year | Executive Territory Account Specialist: $136,800 and $205,200/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Diversity & Inclusion / EEO We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:<ul> <li>Novartis: e-mail [email protected] or call +1 (877)395-2339</li><li>Sandoz: e-mail [email protected] or call: +1-609-422-4098</li></ul> Role Requirements Essential Requirements: &bull; Bachelor's degree required, advanced degree a plus. &bull; 2+ years' experience in specialty pharmaceuticals, biotech, or a sales role of similar complexity within the last 5 years. &bull; Strong ability to collaborate, work cross-functionally within a matrix environment, can communicate clinical product information, has a proven track-record of consistent high-performance, and well-versed in navigating and successfully selling to large accounts and key customer segments. &bull; Self-starter with analytic abilities to seek out, prioritize, and apply relevant information to solve problems to meet the needs of key customers, while also demonstrating ethical leadership and ability to foster environment that promotes ethical behavior and compliance with company policies & laws. &bull; This is a remote position that will support key accounts in an assigned region. Candidate must reside within territory, or within a reasonable daily commuting distance of 50 miles from territory border. Ability to travel 60-80% over a broad geography is required, with the ability to drive and/or fly within the territory. No relocation assistance available. Must have a valid driver's license. Desirable Requirements: &bull; Experience across therapeutic groups, disease states, account management strategy, and new product launches. &bull; Broad understanding in patient services, market access, buy and bill, specialty pharmacy, reimbursement and/or medical calling on HCPs with respect to a sophisticated product or reimbursement pathway. Company will not sponsor visas for this position. Leveling Guidelines: the position will be filled at level commensurate with experience. Territory Account Specialist: &bull; 2+ years' experience in specialty pharmaceuticals, biotech, or a sales role of similar complexity within the last 5 years. Senior Territory Account Specialist: &bull; 5+ years' experience in specialty pharmaceuticals, biotech, or a sales role of similar complexity within the last 5 years. Executive Territory Account Specialist: &bull; 10+ years' experience in specialty pharmaceuticals, biotech, or a sales role of similar complexity within the last 5 years. Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You'll Receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network For Field Roles with a Dedicated Training Period: The individual hired for this role will be required to successfully complete certain initial training, including home study, in eight (8) or fewer hours per day and forty (40) or fewer hours per week. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Allergy Territory Account Specialist - Syracuse, NY - Remote

About the Role Location: Morris Plains, NJ. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. About the role: 365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives. As a Cell Processing Supervisor, you will manage the day-to-day operations on the 2nd shift related to the Processing Unit to produce and deliver the highest quality product in a compliant, efficient, safe, and cost-effective manner. The ideal candidate for this role is a self-starter and has exceptional communication and follow-through with the ability to lead and positively influence others. Key Responsibilities: &bull; Lead and Facilitate Work Cell meetings. Ensures the Work Cell achieves targets for Quality, Safety and Productivity (Production throughout times and batch record review). Compiles area metrics, reports, and performance levels as required. This may include reporting to higher level Management. &bull; Craft Module schedule to ensure business needs are achieved while balancing personnel scheduling adjustments. &bull; Maintaining a daily physical presence with direct reports in the module on and off the shop floor to supervise, coach and support. &bull; Ability to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) areas for extended periods of time. &bull; Provide support to all employees in the area to ensure they are equipped with all tools, training, and documentation to perform their tasks. Ensure associates are demonstrating the proper aseptic techniques & behaviors. &bull; Adhere to all SOPs, cGMPs, and safety rules and regulations and ensure associates are executing tasks per approved policies and applicable procedures. &bull; Work with team to resolve tactical issues and facilitate Corrective Actions and Preventive Actions (CAPAs). Additional Notes: &bull; This position is a PM Shift (12pm-10:30pm) Wednesday-Saturday located on-site at our Morris Plains, NJ facility. Diversity & Inclusion / EEO We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:<ul> <li>Novartis: e-mail [email protected] or call +1 (877)395-2339</li><li>Sandoz: e-mail [email protected] or call: +1-609-422-4098</li></ul> Role Requirements &bull; Bachelor's Degree is required. BS/BA degree in Biotechnology, Biopharmaceutical, Pharmaceutical Technology, Chemistry, Microbiology, Pharmacy, or other Life Science-related scientific degree is preferred. &bull; A minimum of 3 years' experience in cGMP &bull; At least 1 year of Lead/supervisor experience &bull; Proven process understanding (Pharma, GMP, Regulatory aspects) Desirable Requirements: &bull; Cell therapy manufacturing highly desirable &bull; Project management, Operational Excellence, Product/Process Development or Regulatory experience is desired. Pay transparency statement: The pay range for this position at commencement of employment is expected to be between $88,000 and $132,000 year; however, while salary ranges are effective from 1/1/24 through 12/31/24 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Supervisor, Cell Processing - 2nd Shift

About the Role Location: The location for this position will be based out of East Hanover, NJ and will follow a hybrid working model. As the Head of Operations Communications, you will have the exciting opportunity to lead the development and implementation of Novartis' Operations communications efforts. This includes the global product manufacturing and supply chain, global procurement and global Data Digital and IT organizations. Your experience should bring an innovative approach to communications; strong knowledge of best-in-class communications practices and proficiency with next generation communications tools. Major accountabilities: &bull; Act as the business partner for Operations and advise on communications topics as part of the global Operations leadership team. &bull; Counsel the Chief Operations Officer (COO) and guide the development of high-impact internal and external executive communications, including strategy, messaging, talking points, presentations, questions and answers and function-level communications. Has responsibility for Global Operations town halls, placement in external conferences, media, and creation and execution of the COO's LinkedIn strategy. &bull; Develop a communications strategy that highlights Novartis Operations as a key competitive advantage. Proactively seek, bring to life, and scale Novartis stories such as manufacturing wins like the replenishment lead time turn around, demonstrating our resilience and agility managing the ongoing issues, sustainability wins, reimagining manufacturing for the future, etc. Execute with a strong newsroom mindset and editorial strategy to cut through with stakeholders across all internal and external channels - from content for our intranet and other digital tools, to awards and best practice media outlets. &bull; Ensure engagement and inspiration among all of our Operations people around the world by spotlighting and celebrating the work of our people both internally and externally. Recognize the vast talent at Novartis, inspiring and energizing teams to be proud to be part of the Novartis community, and entice new people to join our teams. Drive global patient, purpose and culture stories to connect the dots for floor associates in a language that resonates and elicits pride. &bull; Create a global network of professionals at sites to align initiatives and messaging and ensure cascades of information are effective and implemented. &bull; Foster Novartis' standing in communities where we live and work by providing tools to sites to promote Novartis as employer of choice, as well as support the transformation of Novartis manufacturing and supply chain by aligning our people to the bigger picture and ensuring there is understanding among our people about what needs to change, and why. Support change management efforts. &bull; Develop a narrative for Novartis Data, Digital and IT to position the department as the company's tech backbone and positively highlight the role Data Digital and IT plays in the success of the company. Develop content supporting the narrative and ensure visibility both internally and externally. &bull; Educate our procurement people on our desired procurement future state and how it fits with the overall enterprise strategy. Drive clarity about our expectations and what competitiveness means today. &bull; Lead operations issues and crisis in partnership with global corporate and crisis communications, including disaster and business continuity issues, etc. &bull; Work with country communications and public affairs to develop and execute communications plans for acquisition and divestiture of Novartis sites, as well as collaborate with Environmental, Social and Governance (ESG) office and Global Health communications to support ESG efforts and reporting. This opportunity is located at the Novartis East Hanover (NJ) site and will not have the ability to be located remotely. Relocation assistance may be available. The pay range for this position at commencement of employment is expected to be between $270,400 and $405,600 per year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Diversity & Inclusion / EEO We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:<ul> <li>Novartis: e-mail [email protected] or call +1 (877)395-2339</li><li>Sandoz: e-mail [email protected] or call: +1-609-422-4098</li></ul> Role Requirements What you will bring to the role: &bull; Minimum Bachelor's degree required. &bull; Several years of experience working in corporate communications preferably in manufacturing, supply chain or site communications. &bull; Excellent people and communication skills along with several years of experience in managing, coaching, and developing high performing teams. &bull; Excellent project management skills, accompanied with strong analytical skills and ability to multitask in a fast-paced environment. &bull; Strong influencing, partnering and negotiation skills, with ability to build and maintain strong relationships with clients, agency partners and key stakeholders. &bull; Strategic thinker with strong reporting skills and the ability to identify and highlight opportunities or trends for continuous improvement. &bull; Fluency in English, with strong verbal and writing skills. Desirable skills: &bull; Advanced degree or fluency in an additional language is a plus. Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture Imagine what you could do here at Novartis! Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network #LI-HYBRID Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Head of Operations Communications

About the Role Onsite About the Role: This exciting and influential role is accountable for the oversight, coordination and development of early viability assessments, global feasibility assessments (pre-IMB and trial feasibility), recruitment projections and allocation strategies for the assigned trials and programs. As a key member of the Global Clinical Operations sub-team, the Clinical Operations Program Associate Director provides precise oversight and ensure alignment with the overarching strategy and GCO operational position adding directly into the feasibility strategies. The COP AD's scope of activities will also include pre-IMB project feasibility and/or early viability assessment, trial feasibility assessment, validation and refinement of trial allocation strategy, including scenario planning and risk management, and any re-feasibility assessments, as applicable. Your Key Responsibilities: Lead and conduct the end-to-end feasibility process starting from early viability assessments as well as pre-IMB and trial feasibilities and for developing strategic allocation, site selection and recruitment plans scenarios for the assigned programs and trials. Serve as the point of contact for assigned program and trial feasibilities, leading the multidisciplinary feasibility teams to develop, validate and refine allocation strategy, including timelines, scenarios, and risk mitigation plans. Identify and resolve events in the indication landscape that represent operational risks for the execution of clinical trials within the given indication/program. Lead integration of regional and local indication strategies within global execution plans. Partner closely with the country feasibility team to align on the end-to-end quality of feasibility product Key contributor to the Operational Execution Plan: a. Collection and analysis of internal and external data (i.e. local treatment standard of care, available treatment options approved/reimbursed, local prevalence and access to targeted populations) through analysis of clinical intelligence data describing the indication landscape including scientific and epidemiology data, competitive intelligence, treatment paradigms and potential site partners globally, from external and internal research data sources including analysis of historical data related to site performance (data quality, start-up cycle time, patient enrollment), based on the clinical intelligence package received from the Health Insights Manager and other data sources b. Defines an optimal geographic country footprint and proposed sites for participation in a clinical trial and supports COPH & GCO sub-team on final site allocation. c. Designs and executes the feasibility process by developing feasibility assessment/survey, coordinates execution of feasibility at country level, evaluates prospective sites on their operational and medical capability to conduct the study, and provides a thorough analysis and summary of feasibility outcome to the GCO sub-team d. Develops and proposes risk management strategies for clinical trial(s) highlighting feasibility-related operational risks and mitigation actions for program and trial feasibility and allocation. Responsible for the creation and maintenance of patient enrollment forecast, at study levels Diversity & Inclusion / EEO We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:<ul> <li>Novartis: e-mail [email protected] or call +1 (877)395-2339</li><li>Sandoz: e-mail [email protected] or call: +1-609-422-4098</li></ul> Role Requirements Essential Requirements: Bachelors in life science/healthcare 5+ years of pharmaceutical clinical drug development experience (3+ years in planning/execution global clinical trials) Strong understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, and strong knowledge about the feasibility and allocation process of a program and/or study. Possess strong, resourceful research skills to locate unusual information and have capacity to develop a deep domain specific knowledge base. Understand the Clinical Trial matrixed process from research through post marketing phase IV, health authority guidelines, country challenges as well as sources for therapeutic area data. Demonstrated ability to collaborate across partner functions in a matrix environment, without direct reports, but able to coordinate the activities of others. Demonstrated experience in feasibility for global clinical trials. Preferred Qualifications: Advanced degree or equivalent education/degree in life sciences/ healthcare. Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $151,00 - $226,00/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Clinical Ops Program Associate Director

About the Role Onsite About the role: As a Senior Scientist in the Translational Medicine Drug Disposition Bioanalytical group, you will have the opportunity to make a difference. In this key role, you will use your knowledge of bioanalytics and lab/instrument skills to develop, validate and analyze clinical samples focusing on our novel modality biologics portfolio. If you have a collaborative nature, a commitment to teamwork across an organization and a relentless focus on improving patient care we want you to apply. Your key responsibilities: &bull; Independently designing, developing, and validating assays, and performing sample analysis using biological techniques for PK, PD and immunogenicity following SOPs and guidelines. &bull; Being responsible for all assigned study/lab/project activities and providing input to bioanalytical strategies. &bull; Data processing, evaluating results, interpreting data, and drawing relevant conclusions. Critically analyzing data on study and project levels. &bull; Conducting lab activities and keeping timely raw data records in accordance with company and health authority guidelines. &bull; Preparing study protocols, reports, and contributing to health authority documents. &bull; Maintaining high level of competence on routinely used laboratory equipment and/or LIMS systems. Evaluating and setting up new technologies as they are introduced to the lab. &bull; Contributing to the general lab environment, including instrument maintenance, writing/updating templates and SOPs, software validation activities, ordering supplies, etc. &bull; Coaching and mentoring in a matrix team environment. Diversity & Inclusion / EEO We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:<ul> <li>Novartis: e-mail [email protected] or call +1 (877)395-2339</li><li>Sandoz: e-mail [email protected] or call: +1-609-422-4098</li></ul> Role Requirements Essential requirements: &bull; Bachelor's degree in biological related sciences or equivalent, with 5+ years of relevant experience. Experience in regulated biologics bioanalysis preferred. &bull; Strong laboratory skills with proficiency in several biological techniques (ELISA, ECL, mass spectrometry, PCR, etc.) and their associated software. &bull; Ability to work with minimal supervision and organize work across multiple projects to meet timelines &bull; Eagerness to take on additional responsibilities when required; flexibility to adapt to changing priorities and strategies. &bull; A collaborative spirit and willingness to mentor/coach peers Preferred qualifications: &bull; Advanced degree in biological related sciences Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $97,000 - $146,000/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

GCP - Lab Associate

Site Name: USA - Massachusetts - Cambridge Posted Date: Apr 1 2024 GSK is seeking a highly motivated scientist to join the multidisciplinary Encoded Technologies (ET) team. As a member of the ET Affinity Selections and Biophysics Group, you will support small molecule drug discovery programs across GSK with specific accountability for applying biophysics expertise and techniques in hit discovery and validation, and further developing platform capabilities. Additionally, you will represent the group providing biophysics expertise to cross-functional project teams. The successful candidate will have hands-on experience with biophysics, chemical biology and/or protein biochemistry techniques (e.g., SPR, MST, DSF, affinity purification, alphaLISA, mass-spectrometry). Experience with targeted protein degradation, molecular glues, covalent probes, interrogation of cell lysates, membrane-bound proteins, and/or oligo therapeutics (e.g,. ASOs, AIMers) is a plus. This experience could be from an academic, biotechnology, or pharmaceutical industry setting. We seek a detail-oriented individual with a demonstrated ability to work in a team environment, including good communication and organizational skills, a strong desire to succeed, and the ability to deliver on time. GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent & technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better, & live longer. GSK is headquartered in London, UK with operations in the US; this opening is located at the Cambridge, MA, USA site. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... &bull; Deliver decision-making datasets in support of small molecule hit identification and validation programs &bull; C ontribute to advancing the platform technology via evaluation of new equipment and/or d evelopment and optimization of new methodologies &bull; Become a part of the multidisciplinary Encoded Technologies team while working independently &bull; Interact with other biophysicists, biologists and chemists across multiple GSK R&D sites &bull; Contribute to data analysis and have a chance to further develop analytical skills &bull; Contribute to publications, presentations, and collaborations that enhance the visibility of the team Why You? Basic Qualifications. &bull; BS with 5 years experience or MS degree in biophysics, biochemistry, bioengineering, biology, or similar discipline. Preferred Qualifications &bull; Self-motivated individual with good organizational skills and ability to effectively communicate experimental hypotheses, planning, and conclusions in a clear manner &bull; Ability to work flexibly within a team and in response to changes in strategic prioritization &bull; Experience in biophysical binding techniques, e.g., SPR (especially Carterra LSA), MST, nanoDSF, alphaLISA, trFRET, and/or other similar assays. Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Senior Scientist, Affinity Selections and Biophysics

Site Name: USA - Montana - Hamilton Posted Date: May 1 2024 As a Senior Compliance Specialist, you will support a multi-discipline team whose areas of responsibilities include: Leading investigations, CAPA management, Lean/Six Sigma program, project management within manufacturing and SAP, use of the SAP template with specific focus on the Production Execution (PEX) module of SAP. This role requires you to operate as an internal Manufacturing liaison to other manufacturing teams as well as the following site organizations: Quality, Manufacturing Science and Technology, Technical Services, Environmental Health and Safety, Process Safety Management and Business Process Management This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: <ul><li>Promote a highly safety conscious culture and EHS focused workforce. </li><li>Support department supervisors to ensure that all operations throughout Manufacturing are in accordance to approved GSK process safety standards and OSHA requirements. </li><li>Perform all job responsibilities in compliance with applicable regulations, current operating procedures and industry practice. </li><li>Support integration of overarching Manufacturing systems and procedures to achieve inspection readiness at all times. </li><li>Acquire and maintain knowledge and understanding of SAP Production Execution (PEX) processes and understanding of manufacturing processes in order to manage the flow of materials appropriately. </li><li>Support the integration of new applications with SAP at the Hamilton site (i.e. Manufacturing Execution System (MES)) as well as support Global Business Owners (GBO) in the analysis of the Hamilton site role assignments. </li><li>Perform project management duties related to projects ranging from single department, small scope projects to multi-department, large scope projects.</li><li>Perform and monitor manufacturing processes using a highly automated approach based upon Emerson's Delta V platform. Troubleshoot process deviations resulting from automation communication issues. </li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Bachelor's Degree in any Discipline and 5+ years of cGMP/healthcare/lab related experience OR </li><li>High School Diploma and 10+ years of cGMP/healthcare/lab related experience </li></ul>Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>Regulatory inspection experience</li><li>Knowledge of biological/vaccines manufacturing and its management, including relevant regulations governing the manufacture and supply of pharmaceutical products</li><li>Project management experience and knowledge of best practices associated and clear understanding of project management tools and approaches</li><li>Experience with SAP management demonstrating a quality mindset and knowledge of business processes in the pharmaceutical industry</li><li>Experience with Delta V automation</li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Senior Compliance Specialist

Site Name: USA - Montana - Hamilton Posted Date: May 1 2024 The Automation Engineer will assist the Automation Management in providing automation support to the Value Stream, serving as technical support on small and large projects, and driving alignment of site automation practices with global and industry engineering standards. The Automation Engineer participates in all the technical aspects of automated systems, low voltage systems, and Distributed/PLC controls. Responsibilities include coordination of suppliers, design management, lifecycle code management for automated systems, commissioning, and IQ/OQ for assigned systems. Automation is critical to the modern facility and manufacturing compliance; the Automation Engineer is required to coordinate efforts with other members of local and global teams. The Automation Engineer actively promotes the success of the Automation Engineering group through continual collaboration with the team. The Automation Engineer Champions the voice of the customer in decisions affecting Technical Services resource allocation and project prioritization. Ensure cGMP and ISA compliance of automated systems. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: <ul><li>Assist in ensuring compliance and readiness for internal and external inspections and provide adequate support to inspected departments.</li><li>Support internal, external, and global regulatory agency audits as a subject matter expert.</li><li>Contribute to management of change activities for automation modifications, including management of design document updates, generation of engineering test protocols, and implementation/testing of solutions.</li><li>Generate automation-related deliverables and support automation work for implementation of configuration for small and large projects.</li><li>Actively supports production and facilities teams in investigations and troubleshooting, including participation in rotating on-call support.</li><li>Work with external suppliers to generate budgetary quotes for proposed automation systems, upgrades, and project deliverables.</li><li>Review and contribute to generation of plans for system installation and commissioning.</li><li>Performs triennial SOP reviews as required.</li><li>Performs gap analysis of local SOPs against Global Engineering Standards, GQPs, and GQMPs as required.</li><li>Support key global initiatives such as life cycle management, process data management, alarm management, and cyber security</li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Bachelor's Degree in Chemical, Electrical, Automation, or Computer Engineering</li><li>3+ years specialized automation engineering experience utilizing DeltaV or Rockwell PLCs</li></ul>Preferred Qualifications:<ul><li>Expertise in DeltaV or Rockwell PLC configuration</li><li>Experience in Aveva products for data management</li><li>Understanding of industry standards including ISA S88 Batch controls framework, IEC 61511 Functional Safety standards, and IEC 62443 ICS Cybersecurity standard</li><li>Previous training/continuing education classes around the topics of DeltaV and Rockwell/Allen Bradley products and software</li><li>Configuration and life cycle management experience with DeltaV Safety Instrumented Systems (SIS) logic</li><li>Expertise in DeltaV Live graphics configuration</li><li>Knowledge of virtualized system implementation and management using HyperV</li></ul>#LI-GSK #LI-Onsite Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Automation Engineer

Site Name: USA - Pennsylvania - King of Prussia Posted Date: Apr 16 2024 This is a significant role as part of the Global EHS Team for GSK. You will function as an Industrial Hygiene Subject Matter Expert (SME), helping to set standard for the central organization, and supporting sites, as needed. This focuses on the management of Industrial Hygiene and Ergonomics risks and the reduction of risk and improvement of controls. In role, you will support the management of Industrial Hygiene and Ergonomics within GSK, and primarily support North America manufacturing sites, requiring regional and international travel (from 10-20%) to site locations. This role offers an opportunity to influence Industrial Hygiene risk management within the Biopharma industry. You will have an extensive remit with significant responsibility and visibility across the region. To be successful, you will need the confidence, skill, and technical ability to develop effective working relationships globally and utilize this network to drive improvements in Industrial Hygiene and Ergonomics across GSK. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:<ul><li> Leading Industrial Hygiene and Ergonomics across the region. </li><li> Ensuring an effective chemical, physical, biological, and ergonomic risk management strategy is in place at all sites in the region. </li><li> Providing in-depth technical support to the business in Industrial Hygiene, Ergonomics and other topics as identified. </li><li> Identifying key talent & building organizational capability within region. </li><li> Identifying and mitigating safety & business risks associated with Industrial Hygiene and Ergonomics. </li><li> Managing systems that support risk management initiatives across GSK Sites. </li><li> Working with Engineering and EHS colleagues to build solid business cases for significant capital investments and supporting significant capital investment projects with implementation of GSK standards, from concept to execution. </li><li> Support and collaborate with others on the development and implementation of relevant EHS Standards and technical guidance documents. </li><li> Working in close collaboration with above site Engineering and EHS colleagues to support their activity and leverage any synergies across the network, as well support site teams to cascade and develop improvements, good practice, and innovations. </li><li> Work with Site and regional Capital Engineering to provide input to site Facility Investment Plans to achieve risk reduction initiatives. </li><li> Coordination and management of existing global SME partners, while also building relationships with engineering consultancies to support Industrial Hygiene and Ergonomics programme. </li><li> Developing and presenting insightful data and information to leadership team regarding status and performance against Industrial Hygiene and Ergonomics objectives, and gain support for initiatives. </li><li>Provide proactive and reactive technical support and oversight to audits and incident investigations.</li></ul>Why you? Basic Qualifications: <ul><li>Bachelor's degree level qualification in Industrial Hygiene, EHS, Physical Science or Engineering</li><li>Industry certification (e.g., CIH, CMFOH or locally recognized IH certification)</li><li>8+ years' experience performing IH and Ergonomics risk management activities.</li><li>4+ years Industry experience in a related sector, such as Pharmaceutical, BioPharma, Consumer Health manufacturing or similar</li><li>2+ years' experience and proven technical and leadership skills managing Industrial Hygiene program</li></ul> Preferred Qualifications: <ul><li>Master's degree or equivalent in Industrial Hygiene, EHS, Physical Science or Engineering</li><li>Six Sigma and Lean Manufacturing experience</li><li>Knowledge in the use of the Cority IH Database and Bayesian statistical analysis of data</li><li>Experience in developing containment solutions to manage chemical exposures.</li><li>Regional leadership experience</li><li>S trong relationship building and networking, to engage effectively with a range of stakeholders including EHS and Engineering Regional leads, site personnel, senior management and more </li><li> Strong report writing and presentation skills, and the ability to influence others, deliver training and to develop site employees as you build capability across the network. </li><li> Critical thinking and analytical skills to identify opportunities for simplification and improvement and apply a strategic mindset to deliver work across the network efficiently and effectively. </li><li> Ability to work well in a high-performance team and deliver a variety of work for the Global EHS Team while supporting our manufacturing sites. </li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Regional Industrial Hygiene and Ergonomics Manager

Site Name: USA - Pennsylvania - King of Prussia Posted Date: Apr 1 2024 Thank you for your interest in our Bio Pharm Manufacturing Associate II (Evergreen) position. Applicants for this role will not be receiving immediate feedback regarding their applications. If you are looking for an immediate opportunity, please take a look at the GSK careers page for opportunities that would align with your skill-set. I have included the link here for your convenience: Careers | GSK US . We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021. We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together. As a Biopharm Manufacturing Associate II, you will perform production operations including fermentation or cell culture operations, preparation of solutions, chromatographic separation, filtration and concentration operations, autoclave and parts washing of process assemblies, and area cleaning/upkeep. Will be responsible for completing daily manufacturing tasks, and increasing competency in different production areas over time. Will participate in safety and compliance initiatives, as well as investigations. Will engage in the GSK Production System to continuously improve safety, quality, and schedule/cost performance. The purpose of this role is to be a part of a dynamic, multi-tiered operations team that brings life changing and life saving medicine to patients around the world. They will demonstrate GSK Values (Patient Focus, Transparency, Respect, & Integrity) and Expectations (Courage, Accountability, Development, & Teamwork) on a daily basis by engaging positively with team members and production support groups. Under the direction of senior personnel, the biopharmaceutical manufacturing associate II performs a variety of largescale production operations, interacting with automated equipment and monitoring/processing data. Will be responsible for completing daily manufacturing tasks, and increasing competency in different production areas over time. They will participate in safety and compliance initiatives, investigations, and help solve technical and organizational problems while working with different teams of experts. Will work within these teams to continuously improve safety, quality, and schedule/cost performance. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: <ul><li>Demonstrate GSK Values - Patient Focus, Transparency, Respect, and Integrity - in every interaction, in every work task, and with every responsibility of the job role. Live GSK's Expectations of Courage, Accountability, Development, and Teamwork to achieve high performing behaviors in the workplace.</li><li>With good documentation and data integrity practices, safely and compliantly completes and documents daily manufacturing tasks per standard operating procedures, batch document instructions, and logbooks</li><li>Proactively works with senior staff to achieve competency in production operations</li><li>Supports in cross-functional activities, such as engineering actions, validation actions and Tech Transfer actions, including proactive safety and compliance input prior to execution. Primarily these activities are within the production suite, but sometimes require out of suite or off-site work (i.e. FAT support)</li><li>Monitors equipment and critical process parameters, and escalates any issues or abnormalities and participating the resulting troubleshooting activities</li><li>Strives to maintain a high level of competency with current and emerging digital platforms (SAP, EBR, AR/VR, etc)</li><li>By learning the production schedule and assessing it daily, proactively ensures all processing equipment and necessary materials are adequate and available to set the team up for success</li><li>Transparently participates in investigations that are the result of safety or compliance issues.</li></ul>Why you? Basic qualifications:<ul><li> BS/BA degree, with cGMP manufacturing experience </li><li> OR an Associate's degree from Montgomery county community college in Biotechnology or related technical field with cGMP manufacturing experience </li><li> OR High School degree, 1+ years of cGMP manufacturing experience. </li></ul> Preferred Qualifications:<ul><li> Demonstrated level of high performance </li><li> Strong verbal and written skills </li><li> The ability to work well in a team environment </li><li> Must be able to follow detailed processing instructions as well as accurately documenting all necessary documentation. </li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Biopharm Manufacturing Associate II

Site Name: Collegeville TSA Posted Date: Apr 1 2024 Are you looking to enhance your immunoassay development techniques by working for a global pharmaceutical company that allows you to leverage best in class systems and technologies? If so, this Immunoassay Investigator role is the ideal opportunity for you. We are looking for a highly motivated, flexible and experienced scientist to join a team within the Biomarker Platforms department based in Collegeville, PA. As an Immunoassay Associate Director, you will be responsible for the development, validation and sample analysis of PK assays for use in support of clinical programs in alignment with therapy area partners. Data from this group is a key component to understanding molecules in the GSK pipeline; and serves to make early and informed decisions for asset progression within the organization. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:<ul><li>Responsible for developing bespoke assays to support clinical studies; delivery of robust, high quality data packages and will demonstrate the ability to critique work to enable lead modalities to be smoothly progressed through clinical drug development.</li><li>Independently providing sample analysis support for clinical studies by delivering high quality data packages working in a GLP/GCP compliant laboratory setting.</li><li>Deliver, interpret and communicate complex scientific data to project/program teams in a timely manner by performing data analysis, record keeping and reporting of results to agreed timelines.</li><li>Works and communicates effectively with the group and speaks up when necessary.</li><li>Contribute to departmental strategy and capital investment discussions.</li><li>Handling of human biological samples and performing experimental work in accordance with HBSM, safety and data integrity guidelines. </li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>PhD in Biology, Biochemistry, Immunology or related discipline with ≥5 years or BS/MS with ≥10 years of experience in a regulated pharmaceutical or biotechnology environment with a thorough understanding of the drug development process.</li><li>Three or more years of hands-on experience and theoretical understanding of clinical immunoassay development, validation and study support for either PK or biomarker (ELISA/MSD/Gyros).</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>Proven ability to provide translational expertise on programs/project teams for clinical studies with a wide variety of techniques and technologies. </li><li>Strong publication/presentation history</li><li>Biomarker experience is a plus</li><li>Maintains a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor and operational excellence.</li><li>Attention to detail and good communication and documentation skills will be expected. </li><li>Highly motivated team player with a proactive attitude, excellent organizational skills and a demonstrated ability to interact effectively within a multi-disciplinary team are essential.</li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Immunoassay Associate Director, LBA

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Apr 1 2024 We are looking for a highly motivated, flexible and experienced scientist to join the Cellular Biomarkers Flow Cytometry team within Biomarker & Bioanalytical Platforms in the Precision Medicine department located in Upper Providence, US. The team is responsible for the development and validation of complex multi-parameter flow cytometry panels and subsequent application of these panels to clinical trial sample analysis. The deep immunophenotyping data generated by these biomarker panels helps us to evaluate disease heterogeneity, drug-target engagement, drug mechanism of action and patient responses. The successful candidate will have a deep understanding of immunology and will act as a flow cytometry technical expert, supporting high parameter deep immunophenotyping of immune cell subsets as well as receptor occupancy endpoints. This is a lab-based role and will include all aspects of flow cytometry method development and optimization, validation and sample analysis for clinical studies across the entire GSK portfolio. This role will be responsible for completion of all aspects of assay workflow including reagent selection, sample preparation, sample acquisition, data analysis, interpretation and presentation. In addition, this role will ensure all work is conducted in compliance with GCP regulations including adherence to the appropriate SOPs. In this role you will <ul><li>Generate high quality data to support clinical studies by spectral flow cytometry (Cytek Aurora)</li><li>Conduct and oversee all aspects of method development, troubleshooting, validation and sample analysis for clinical studies</li><li>Handle human biological samples and perform experimental work in accordance with GCP regulations, safety assessments and data integrity guidelines</li><li>Be responsible for delivery of robust, high-quality data packages</li><li>Deliver, interpret and communicate complex scientific data to project/program teams within agreed timelines</li><li>Contribute to biomarker strategy and capital equipment discussions</li><li>Help lead efforts to investigate novel cytometry and data analysis platforms and embed them within the organization</li><li>Manage multiple projects concurrently</li><li>Function well in a team and possess a good balance of creative and analytical skills</li><li>Be willing to develop and train others as required</li></ul>Why you? Basic Qualifications: <ul><li>Bachelors degree and six or more years' relevant experience or PhD with two or more years' experience</li><li>Two or more years' experience with immunological enabling phenotyping of multiple cell lineages</li><li>Two or more years' experience with flow cytometry and in design and execution of 16+ colour flow cytometry panels</li><li>Two or more years' of laboratory experience and expertise working with a variety of sample types including whole blood, PBMC, cell lines and single-cell suspensions from tissues</li></ul> Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus: <ul><li>A good understanding of the drug development process</li><li>Experience in design and execution of 22+ colour flow cytometry panels</li><li>In-depth knowledge of various immune subsets</li><li>In-depth knowledge of receptor occupancy assays</li><li>Hands on practical experience with the Cytek Aurora</li><li>Strong laboratory experience and understanding of clinical and non-clinical flow cytometry biomarker assay development, validation and implementation</li><li>Hands on experience with high-dimensional data analysis ( e.g. tSNE, UMAP, CITRUS, FlowSOM)</li><li>Experience of technology transfer of flow cytometry assays to Contract Research Organizations</li><li>Experience of writing SOPs and other regulated documents</li><li>Willingness to work with human samples infected with blood borne pathogens including HIV and HBV, etc.</li><li>Considerable experience in the use of flow cytometry analysis software (OMIQ preferred)</li><li>Ability to maintain a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor, and operational excellence even when flexing between multiple projects</li><li>Attention to detail, good communication and documentation skills</li><li>Ability to work independently to tight deadlines with a proactive attitude</li><li>Be a highly motivated team player with the ability to interact effectively within a multi-disciplinary team</li><li>Ability to problem solve and troubleshoot</li><li>Good judgment and decision making, especially for prioritizing multiple requests</li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Principal Scientist, Flow Cytometry

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Apr 2 2024 Are you an ambitious Oncology Clinical Development professional looking to advance your career in the pharmaceutical industry? Take a look at this position and engage with us to explore broader opportunities in GSK's Oncology Clinical Development division today. The Medical Director Oncology Clinical Development will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK's clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant scientific and medical leaders in order to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key External Experts. This role requires a physician capable of developing and executing oncology clinical trials in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents. Key Responsibilities<ul><li>Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials</li><li>Ensure high quality protocol development aligned with the Clinical Development Plan to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe. </li><li>Use medical expertise to contribute to the end to end (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into decision making </li><li>Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population. </li><li>Assume medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and medical data review.</li><li>Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.</li><li>Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.</li><li>Collaborate with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data.</li><li>Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of GSK's vision.</li><li>Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature. </li><li>Serve as a core member of the Clinical Matrix Team for one or more assets in development.</li><li>Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.</li><li>Participate in Oncology Clinical Development-wide initiatives and workstreams as appropriate.</li></ul> *LI-GSK Basic Qualifications Include: <ul><li>Medical degree with board certification/eligibility or registration qualifications in medical oncology, hematology or internal medicine (with hematology or oncology experience)</li><li>Academic and/or clinical research publications or clinical medical practice in the field of oncology.</li><li>Clinical drug development process experience in the conduct/participation of clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.</li><li>Regulatory experience to support registration and GCP principle</li></ul>Preferred Qualifications include:<ul><li>Strong experience in pharmaceutical industry or related oncology clinical practice experience</li><li>Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution</li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Expressions of Interest - Oncology Clinical Development Physicians

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Apr 30 2024 This role will be located in Collegeville, PA and will require the new employee to work 5 days a week onsite to support our employees working in the Laboratory. We are looking for a highly motivated, agile and experienced immunologist to lead our Cellular Biomarkers Flow Cytometry team within the Biomarker and Bioanalytical Platforms department. Our group is responsible for developing and validating complex multi-parameter biomarker assays for use in clinical studies. We generate deep immunophenotyping data to evaluate disease heterogeneity, drug-target engagement, drug mechanism of action and patient responses. The successful Director, Flow Cytometry US Group Leader will have a deep understanding of immunology and will serve both as a group leader and as a technical expert. Key Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: <ul><li>Provide scientific leadership and guide the development and validation of various high parameter spectral (Cytek Aurora) flow cytometry assays including deep immunophenotyping of immune cell subsets and receptor occupancy endpoints.</li><li>Oversee all aspects of method development, troubleshooting, validation and sample analysis for those clinical studies withflow cytometry endpoints.</li><li>Manage, develop and train a team of PhD and non-PhD scientists</li><li>Provide biomarker/translational expertise on multiple clinical programs/projects including influencing biomarker strategy</li><li>Be responsible for delivery of robust, high-quality data packages</li><li>Ensure all work is conducted in compliance with GCLP regulations and follow the appropriate SOPs.</li><li>Guide your team in successful interactions with CRO partners to assist in the delivery of high-quality clinical flow cytometry endpoints</li><li>Deliver, interpret and communicate complex scientific data to project/program teams within agreed timelines</li><li>Ability to handle multiple projects concurrently</li><li>Able to function well in a team and possess a good balance of creative and analytical skills</li><li>Contribute to capital equipment discussion</li><li>Lead efforts to investigate novel flow cytometry data analysis platforms and embed them within the organization</li></ul>Why You? Minimum Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li>PhD in immunology, cell biology or similar field</li><li>6 or more years post-PhD work experience in immunology, cell biology, or biomedical science</li><li>Experience in biomarker/translational work on multiple clinical programs/projects</li><li>People leadership experience of a large team ( 10 to 15 direct reports) and ability to lead a team of PhD and non-PhD level scientists</li><li>Experience in immunology covering phenotyping of multiple lineages of cells</li><li>Laboratory experience working with clinical and non-clinical flow cytometry biomarker assay development, validation, and implementation</li><li>Experience in high dimension flow cytometry and in the design and execution 16+ color flow cytometry panels</li><li>Experience in the use of flow cytometry analysis software like OMIQ</li><li>Experience working with a variety of sample types including whole blood, PBMC, cell lines and single-cell suspension from tissue samples</li></ul>Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>Excellent collaboration and interpersonal skills to influence biomarker testing strategies and communicate efficiently with colleagues from all phases of clinical drug development</li><li>Ability to maintain a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor, and operational excellence</li><li>Ability to problem solve and troubleshoot</li><li>Demonstrated judgment and decision making, especially for prioritizing multiple requests</li><li>Experience in the development and validation of novel flow cytometry assays to support clinical measurements and their translation to a companion diagnostic (CDx) when applicable.</li><li>Experience of working with external vendors for the transfer of assays to support clinical trial sample analysis and development of CDx (where appropriate)</li><li>Experience to design and execute 25+ color flow cytometry panels</li><li>Hands on experience with the Cytek Aurora</li><li>Hands on experience with OMIQ</li><li>Proactively demonstrate the ability to work to tight deadlines</li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Flow Cytometry US Group Leader

Site Name: USA - Pennsylvania - Marietta Posted Date: May 1 2024 Are you interested in leading a team responsible for the delivery of automation and controls systems at an important sterile drug product manufacturing site? Are you interested in delivering innovative technology and building a team to be successful? If so, this Automation Manager role could be an excellent opportunity for you to explore. *The position has the flexibility to be performed as a Secondment or Full-time opportunity. The Hiring Manager will discuss additional details on options available during the interview process.* As an Automation Manager, you will be responsible for the team accountable for successful investment related to automation, controls, and digital, data & analytics (DDA) implementation. Team responsibilities include the ideation, specification, design, delivery, construction, start-up, and qualification of instrumentation, controls, and execution digital systems for all aspects of drug product manufacturing including formulation, filling, assembly, packaging, and support infrastructure (utilities, labs, warehousing). This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... <ul><li>Direct operational and technical stewardship of delivery of digital assets and solutions at all network levels, including Level 3 - Execution systems (e.g. MES, LES), Level 2 - Control systems (e.g. DCS, BAS), and Level 1 (e.g. IoT).</li><li>Direct engineering and technical efforts in the design, specification, procurement, and deployment of automation and digital assets & applications. Direct automation and coding efforts in the design, implementation, and operational support of automated and digital solutions across site.</li><li>Assure that all digital operations are compliant with GSK guidelines/standards, safety regulations, and quality requirements, especially as they pertain to cyber security and data integrity.</li><li>Assure business continuity in all aspects of automated solutions and digital operations, including but not limited to: network and system security against cyber threats, data integrity and availability, critical spares, asset supportability, and license to operate it pertains to EHS and Quality Compliance.</li><li>Create, own, and deliver the investment according to the site's digital strategy:<ul><li>Delivers measurable value to the business and aligns with broader objectives and strategy.</li><li>Advances the site's digital posture.</li><li>Better aligns the capability and composition of the site's workforce with its digital trajectory.</li><li>Drive maturity in the space of digital solutions and data-based insights.</li><li>Drive value to the business through innovation and transformational technologies such as AR/VR, robotics, biometrics, and ML/AI.</li><li>Own and manage project relationships with PSC Tech and other DDA stakeholders.</li></ul></li><li>Guide / mentor / coach team as they deliver scope - support their generation of possible solutions and the selection and buy-in of the final solution. Follow-up to ensure the solution is implemented appropriately and satisfies the customer's requirements.</li><li>Develop high-performing engineers into experienced leaders and experts in manufacturing capable of leading the business outside engineering.</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li> BS/BA in engineering, computer science, or equivalent technical discipline </li><li>8+ years of automation or digital operations experience with at least 5 years in a manufacturing or life sciences environment. Prior experience directly managing a technical staff and remit related to automation or digital operations.</li><li> Experience working in a regulated GMP environment. </li><li> Pharmaceutical/biotechnology industry experience. </li><li> Prior project engineering and/or technical management experience. </li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li> MBA with Digital Specialization, master's in engineering, Masters in CS </li><li> Professional Engineering (PE) license or Chartered Engineering status preferred. </li><li> Demonstrated ability to interact well with peers and across all levels of the organization. </li><li>Demonstrated effective management of significant capital and ownership of systems subject to audits from oversight groups and regulatory bodies.</li><li>Demonstrated capability of leading large matrix organizations with excellent communication, influencing, and coaching abilities at all levels within the organization</li><li>Leadership skills that enable the introduction of new ways of working and accelerated change management</li><li>Proven capability to lead and motivate teams (line & matrix; and multi-disciplinary & cross-functional) to deliver business solutions and benefits.</li><li>Must be able to interact well with peers, subordinates, and senior personnel in scientific, engineering, and operational disciplines.</li><li>Demonstrated ability to participate as a leader or member on cross-functional and self-directed work teams.</li><li>Must be comfortable and thrive in ambiguity and think strategically to solve complex problems. </li><li> Demonstrated ability to lead and inspire technical groups. </li><li> Proficient with application and administration of manufacturing control systems, building automation systems, servers, industrial communications/LAN, and data historians. </li></ul>#LI-GSK #Globalsupplychain #MariettaGSC #Vaccinessupplychain Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Automation Manager

Site Name: USA - Pennsylvania - Marietta Posted Date: May 1 2024 Are you interested in leading a team responsible for the validation of equipment and systems at an important drug substance and drug product manufacturing site? Are you interested in delivering innovative technology and building a team to be successful? If so, this Validation Manager role could be an excellent opportunity for you to explore. *The position has the flexibility to be performed as a Secondment or Full-time opportunity. The Hiring Manager will discuss additional details on options available during the interview process*. As a Validation Manager, you will be responsible for leading the team responsible for validation of equipment and facilities for the manufacture of biological drug substance and sterile drug product. Validation team responsibilities include the strategy, planning, execution, completion, and maintenance protocols to ensure all processes used in manufacturing and testing remain in a validated state. Fluency in (bio)pharmaceutical processes, facilities, operations, validation methods, and GSK standards in project management, validation, quality, and EHS are essential. Individual management of individual protocols also foreseen. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:<ul><li>Lead a team of validation engineers who are individual experts in area specific bioprocess equipment and facility and control system validation. The quality of the validation program has a direct impact on compliance to cGMP's and the ability of the supply chain to gain regulatory approval to manufacture.</li><li>Test and successfully introduce new equipment and processes into the facility - including drug substance unit operations such as buffer preparation, UFDF, mixing, and homogenization and drug product unit operations such as formulation, filling, assembly, and packaging. </li><li>Fluent in quality by design and validation industry standards for equipment and facilities and also innovations in validation execution. Familiar with statutory guidance and GSK standards for above. </li><li>Define and optimize the overall validation strategies, policies, and programs. Strategic planning to include benchmarking against industry trends as well as continuous improvement in the validation program against current compliance standards and regulations.</li><li>Manage the development and execution of validation protocols for all facility services, utilities, equipment, cleaning, maintenance, and systems including computer systems.</li><li>Manage the development, implementation, and maintenance of validation documentation. </li><li>Interface with regulatory inspectors on all validation issues, and present and defend the validation program in regulatory audits.</li><li>Provide validation technical assistance to other GSK organizations when needed. Participate in cross organizational validation discussion and development efforts.</li><li>Interface with Automation, Environmental, Health & Safety, MSAT, Manufacturing, Quality, and Corporate Engineering groups to assure that each project conforms to approved user requirements.</li><li>Guide / mentor / coach team - support their generation of possible solutions and the selection and buy-in of the final solution. Develop high-performing engineers into experienced leaders and experts in manufacturing capable of leading the business outside engineering.</li><li>Ensure EHS corporate standards, local legislation, and other Quality and Regulatory requirements are included while planning and executing all projects. Also, ensure proper identification and assessment of potential EHS risks that are significant to the business and that can be eliminated or minimized before or during project implementation. </li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Bachelor's degree in engineering or equivalent technical discipline; Mechanical or Chemical Engineering </li><li>10+ years of pharmaceutical industry validation experience</li><li>Experience leading technical teams.</li><li>Experience with regulatory compliance.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li> MBA, master's in engineering, and/or Professional Engineer </li><li>10+ years of prior project and/or operational validation experience in the pharmaceutical industry is preferred. </li><li>Prior project experience in the design, construction, start-up and operation of large bulk biopharmaceutical drug substance AND drug product fill / finish facilities.</li><li>Familiar with cGMPs, PDA, FDA regulations.</li><li>Detailed understanding of Design, Installation, and Commissioning / Qualification / Validation of new pharmaceutical equipment and/or utilities.</li><li>Must be able to interact well with peers, subordinates, and senior personnel in scientific, engineering, and operational disciplines.</li><li>Demonstrated ability to participate as a leader or member on cross-functional and self-directed work teams.</li><li>Must be comfortable and thrive in ambiguity and think strategically to solve complex problems. </li><li>Sense of Urgency / Decision making.</li><li>Strong interpersonal skills.</li><li>Must be able to work within a multi-disciplinary team environment.</li><li>Must be able to generate options to resolve problems, prioritize solutions and implement decisions.</li><li>Must be competent in handling simultaneously occurring tasks and have excellent written and oral communication skills.</li></ul>#LI-GSK #Supplychaincritical #MariettaGSC #MariettaVaccines Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Validation Manager

Site Name: USA - Pennsylvania - Marietta Posted Date: May 1 2024 The Quality Systems Manager is responsible for developing and administrating support systems for the production of biologics at the Marietta facility. The Quality Systems Manger is accountable for ensuring that all cGMP systems are compliant with GSK internal procedures, policies, standards, and applicable government cGMP regulations. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: <ul><li>Lead the QA Systems team and ensure that all team members display a quality mindset in their performance and behaviors. </li><li>Identify the strengths of each team member and ensure that each team member is a good fit for their role. </li><li>Accountable for development of the QA systems team.</li><li>Accountable for the management of all cGMP quality systems (includes deviations, CAPAs, change control, QMS, and others). </li><li>Accountable for the management of Documentation systems (including procedures management, equipment logbooks, archival, and others).</li><li>Accountable for developing and maintaining visual process maps that describe each cGMP system, the interaction between cGMP systems, and the accountabilities and responsibilities of roles in each cGMP system. </li><li>Accountable for integrating cGMP system maps with the SAP business process diagrams developed and maintained by business process owners (in Operations, Quality Unit, and LTS) so that data movement, document flow, logical process flow, and workflow can be shared and communicated comprehensively (or separately, as needed) and clearly. </li><li>Accountable for continuously driving improvement in business processes and business systems to improve compliance and productivity over time.</li><li>Accountable for post-marketing surveillance (complaints and PQR systems and processes).</li><li>Accountable for maintaining the relationships between local cGMP system owners and cGMP system owners at other sites and in global functions in order to share good practices, learning, and system issues and improvements.</li><li>Accountable for leading or managing quality systems improvement and simplification projects and site initiatives as applicable.</li><li>Accountable for routinely, frequently, and accurately measuring and communicating the suitability (fit for use), performance, compliance, and effectiveness of cGMP systems.</li><li>Maintain all systems in a state of continuous readiness for regulatory inspections.</li><li>Accountable for the Quality escalation and Quality alert processes. Act as the site single point of contact to Regional QA for escalation events and quality alerts. Ensure that each escalation event is closed and status is reported back to Marietta.</li><li>Responsible for compliance with the GSK safety procedures and all applicable EHS regulations, standard operating procedures, and industry practices.</li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li> BS or BA in a Science discipline. </li><li> Minimum of 5 years' prior experience supervising quality assurance (Quality Systems, compliance, product release) within clinical or commercial organization. Supervision to include delegating, training, communicating and prioritizing site objectives, evaluating, coaching and discipling others. </li><li> Minimum of 3 years' prior experience with licensed biopharmaceutical or biological products </li></ul>Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li> Master's degree in science or business discipline. </li><li>Versed in GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to comply to quality operations and compliance.</li><li>In-depth experience in quality systems, including validation, documentation, compliance in a high volume, rapid turnaround release office or compliance department. </li><li>Strong technical understanding of industry and science practices related to the business</li><li>Strong communication and problem solving skills with a demonstrated ability to work well with and influence others without direct reporting relationships</li><li>Formal training in quality systems design or administration by a recognized industry organization such as ASQ.</li><li>Lean / six sigma training (green belt, black belt, master black belt certification).</li></ul> #LI-GSK #GSKMarietta #MariettaGSC Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Quality Systems Manager

Site Name: USA - Pennsylvania - Marietta Posted Date: May 1 2024 Are you interested in leading a team responsible for engineering at an important drug substance and drug product manufacturing site? Are you interested in delivering innovative technology and building a team to be successful? If so, this Process Engineering Manager role could be an excellent opportunity for you to explore. *The position has the flexibility to be performed as a Secondment or Full-time opportunity. The Hiring Manager will discuss additional details on options available during the interview process*. As a Process Engineering Manager, you will be responsible for leading the team responsible for engineering of equipment and facilities for the manufacture of biological drug substance and sterile drug product. Engineering team responsibilities include the design, delivery, construction, start-up, and qualification of process equipment and areas including drug substance purification, drug product formulation, filling, assembly, and packaging. Responsibilities are by first intent for projects executed within the US. Fluency in (bio)pharmaceutical processes, facilities, operations, engineering methods, and GSK standards in project management, operations, quality, and EHS are essential. Individual management of individual processes and equipment also foreseen. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:<ul><li> Lead a team of process engineers who are individual experts in area specific bioprocess equipment and facility design / operation. </li><li> Deliver new equipment and processes into the facility - including drug substance unit operations such as buffer preparation, UFDF, mixing, and homogenization and drug product unit operations such as formulation, filling, assembly, and packaging. </li><li> Support the construction, commissioning, qualification, and 24/7 manufacture of vaccines and medicines critical to patient quality of life and support critical revenues for the company. On-call support for manufacturing troubleshooting and planned upgrades is a team necessity. </li><li> Fluent in biopharma industry standards for equipment and facility design for cleanability and bioburden control. Expert in CIP/SIP design and operational principles. Familiar with statutory guidance for above (ASME BPE, ISPE). Fluent in sterile fill industry standards for equipment and facility design. </li><li> Manage efforts and resources required by project teams to meet technical, budget, and schedule goals. Expert in multi-tasking, scheduling, budgeting, and project management. Familiarity with equipment supplier, preferred subcontractor, and consultant engineering markets to support site projects as needed with competitive cost and service. </li><li> Interface with Automation, Environmental, Health & Safety, MSAT, Manufacturing, Quality, and Corporate Engineering groups to assure that each project conforms to approved user requirements. </li><li> Guide / mentor / coach team as they deliver equipment and facility packages - support their generation of possible solutions and the selection and buy-in of the final solution. Follow-up to ensure the solution is implemented appropriately and satisfies the customer's requirements. </li><li> Develop high-performing engineers into experienced leaders and experts in manufacturing capable of leading the business outside engineering. </li><li> Ensure EHS corporate standards, local legislation, and other Quality and Regulatory requirements are included while planning and executing all projects. Also, ensure proper identification and assessment of potential EHS risks that are significant to the business and that can be eliminated or minimized before or during project implementation. </li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Bachelor's degree in engineering or equivalent technical discipline.</li><li>10+ years in Engineering and Plant Operations</li><li>Experience with biopharmaceutical equipment and manufacturing processes.</li><li>Experience managing capital and systems subject to audits from regulatory bodies.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>Master's degree in engineering</li><li> 10+ years of prior project and/or process engineering experience in the pharmaceutical industry is preferred. </li><li> Prior project experience in the design, construction, start-up and operation of large bulk biopharmaceutical drug substance AND drug product fill / finish facilities. </li><li> Demonstrated ability to manage projects >$10m to completion on time and within budget (minimum), preference for >$50m. </li><li> Familiar with cGMPs, GEPs. </li><li> Detailed understanding of Design, Installation, and Commissioning / Qualification / Validation of new pharmaceutical equipment and/or utilities. </li><li> Must be able to interact well with peers, subordinates, and senior personnel in scientific, engineering, and operational disciplines. </li><li> Demonstrated ability to participate as a leader or member on cross-functional and self-directed work teams. </li><li> Must be comfortable and thrive in ambiguity and think strategically to solve complex problems. </li><li> Sense of Urgency / Decision making. </li><li> Strong interpersonal skills. </li><li> Must be able to work within a multi-disciplinary team environment. </li><li> Must be able to generate options to resolve problems, prioritize solutions and implement decisions. </li><li> Must be competent in handling simultaneously occurring tasks and have excellent written and oral communication skills. </li><li> Project Management Professional Program Certification or Professional Engineer license </li></ul>#LI-GSK #Supplychaincritical #MariettaGSC #MariettaVaccines Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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