Senior Associate Scientist, Cell Banking (4843705_Andover)
Senior Associate Scientist - Cell Banking is part of a cell bank manufacturing team focused on cGMP microbial and mammalian cell bank preparation, storage, inventory management, and distribution to end users. The focus of this position involves conducting operations according to approved SOPs and batch records, maintaining and operating associated equipment, revising SOPs and batch records, storing and managing cell bank inventory, cell bank distribution as needed.
The successful candidate will be part of a team of scientists and technicians focused on manufacturing, testing and managing mammalian and microbial cGMP cell banks for production of vaccines, cell and gene therapy and protein Biotherapeutics.
The incumbent will be engaged in cell culture, filling and cryopreservation activities required for cGMP cell bank manufacturing, post-bank assessments, as well as performing storage, cell bank inventory management, and shipping activities. They will also lead technology transfer, equipment lifecycle and facility maintenance activities, investigations, and process improvement initiatives.How You Will Achieve It
Conduct cell bank manufacturing operations as required to meet the plan of record.
Follow and adhere to cGMP documentation practices, operational procedures, and compliance procedures.
Adhere to safety procedures and guidelines by practicing and promoting safe work habits.
Lead technology transfer efforts including qualification and logistics associated with new raw materials
Lead equipment lifecycle and new technology assessment activities including equipment suitability, qualification and implementation.
Author and revise SOPs, master batch records and campaign summary reports.
Maintain cell banking facility and equipment in a constant state of operational and audit readiness.
Lead investigations and implement process improvements.
Collaborate with partners from diverse cross-functional lines to effectively resolve events and issues.
Understand scientific principles in order to identify and solve moderately complex problems.
Make sound and compliant decisions with minimal input that may require choosing from limited options.
Think critically and facilitate the drive towards continuous improvement.
Effectively manage own time and balance workload priorities.
- Associate’s degree with 5-8 years of experience or Bachelor’s degree with 2-4 years of experience in a biological or engineering discipline (Biotechnology, Chemistry/Biochemistry, Chemical/Biochemical Engineering, or similar).
- Experience with investigations, equipment validation, or material management is highly desired.
- Experience in mammalian and/or microbial cell culture in a GMP setting with strong aseptic technique, experience working in a cleanroom a plus.
- Experience in cGMP compliance and regulatory compliance requirements as related to manufacture of biologics, experience with GMP cell bank preparation a plus.
- Understanding of scientific principles, ability to think critically and demonstrate troubleshooting and problem-solving skills.
- Strong workload planning / prioritization skills, organization, and attention to detail, and follow through.
- Ability to learn new techniques quickly and follow established protocols with precision
- Excellent communication and presentation skills
- Experience working with computerized systems (Electronic notebook and GMP inventory management systems a plus).
- Experience in authoring SOPs, MBRs, protocols.
- Experience with equipment validation and lifecycle management a plus
- Experience with raw material testing regulations a plus
- Must be able to gown into cleanroom environment and be standing for ~2-3 hours at a time.
- Must be able to perform simple mathematical calculations.
- Must be able to manipulate screw-cap vials inside a BSC and aseptically fill at least 200 vials in a single setting.
- Must have practical knowledge of the use of Personal Protective Equipment (PPE) to handle hazardous materials throughout site.
- Must be able to gracefully manage non-ideal situations under stress.
- Must have a change-agile growth mindset for navigating changing needs and priorities.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Ability to work in a clean room environment.
- Ability to work standing for long periods of time.
- This is mainly a 1st Shift position (M-F) that will also require occasional alternative shift and/or weekend work.
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.
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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.Research and Development#LI-PFE