Technical Associate, Clinical Manufacturing (4840901_Andover)
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.What You Will Achieve
You will be part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. Your initial focus will be as part of the fermentation suite startup team to prepare the facility for operational readiness. This includes and not limited to supporting the manufacturing operations team, reviewing Standard Operating Procedures, reviewing batch records, and standard work. You will also support commissioning and qualification of process equipment. After the startup of the facility, you will transition to a team that will be responsible for the execution of microbial upstream and downstream processes.
As part of technical operations, you will be a team member who is relied to have a good understanding of procedures, techniques, tools, materials and equipment. Your decision making will help you prioritize workflows based on the available resources. You will follow standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. You will contribute to the team’s success by sharing of previously acquired knowledge.
It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Adhere to scheduled shift hours and own your own professional development, be accountable for own results and begin to prioritize own workflow.
Cross-functional communication with Process Development, Tech Transfer team, Quality, Warehouse Inventory Management, Media Solutions Prep, Maintenance, and Engineering as necessary.
Implement Good Manufacturing Practices and safe handling techniques.
Ability to follow Standard Operating Procedures and, when trained, work within a team under minimal supervision/oversight.
Participate in continuous improvement initiatives and root cause analysis.
Execute documentation (both Electronic and Paper) associated with clinical manufacture, such as, Working Batch Record documentation, logbooks, forms, etc...
Complete activities with the maintenance and operation of manufacturing equipment.
Actively participate in shift exchange activities and communication channels.
Complete required compliance and safety trainings.
Participate in safety inspections within the facility.
Maintain the cleanliness and compliance of manufacturing suites.
Understand and comply with the policies, procedures and working practices of Environment, Health & Safety and where necessary contribute to the review and implementation of the practices in the plant.
Manage stocking and inventory of production consumables.
Participate in the coordination of day to day operations within the team.
High School Diploma or GED
Interest in learning scientific theory and ability to apply concepts to manufacturing work
Operational knowledge of computerized systems or automation
Familiarity with Production Control Systems, Enterprise Resource Planning Systems and other business systems
Maintains a safe work environment
Demonstrated capability to work as a team member in a matrix development team
Mechanical aptitude and desire to execute hands on
Excellent communication skills, strong interpersonal skills, and ability to thrive in a dynamic environment.
Strong computer skills in Microsoft Office required, especially MS Word, MS Excel
Bachelor's Degree in field of scientific study
Demonstrated experience in a biotechnology manufacturing or laboratory environment
Knowledge of fermentation and or downstream processing techniques
Experience with DeltaV, Axis360, Trackwise, electronic batch records, logbooks, maintenance systems
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Manufacturing