Scientist, QC Microbiology, Cell Therapy
Bristol Myers Squibb
August 16, 2026
Remote friendly (Devens, MA)
United States
Operations
Position Summary
- Subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples. Perform data review/verification, complex troubleshooting, and method training. Own project, document revisions, deviations/investigations/CAPA, and continuous improvement efforts.
Key Responsibilities
- Support method transfer/verification/validation and routine testing of in-process, final product, and stability samples.
- Review testing data (e.g., data packets, final lot file, COA review).
- Independently perform complex troubleshooting and problem solving.
- Verify/review data and GMP documentation for multiple (general and complex) methods and/or products.
- Own CAPA and deviation/investigation related tasks and/or continuous improvement efforts.
- May represent the department in regulatory inspections (internal/external audits).
- Train and mentor others on QC test methods, processes, and procedures.
- Cross-train on complex microbiology methods and/or multiple products.
- Author/revise technical documents (test methods, SOPs, specifications, trend reports, and/or sample plans) as appropriate.
Qualifications & Experience
- Bachelor’s degree or equivalent (preferably science); advanced degree preferred.
- 6+ years relevant microbiological testing or QC experience (preferably in a regulated environment).
- Demonstrated microbiological techniques.
- Ability to understand and apply Global Regulatory and cGMP requirements.
- Demonstrated technical writing skills.
Skills (Required/Preferred)
- Strong problem-solving, technical reasoning, and communication with peers and cross-functional partners.
- Ability to work in a fast-paced team, meet deadlines, and prioritize multiple projects.
- Preferred: advanced knowledge of LIMS/ELN and lab data analysis systems.
- Strong mentoring/coaching/influencing skills.
- Subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples. Perform data review/verification, complex troubleshooting, and method training. Own project, document revisions, deviations/investigations/CAPA, and continuous improvement efforts.
Key Responsibilities
- Support method transfer/verification/validation and routine testing of in-process, final product, and stability samples.
- Review testing data (e.g., data packets, final lot file, COA review).
- Independently perform complex troubleshooting and problem solving.
- Verify/review data and GMP documentation for multiple (general and complex) methods and/or products.
- Own CAPA and deviation/investigation related tasks and/or continuous improvement efforts.
- May represent the department in regulatory inspections (internal/external audits).
- Train and mentor others on QC test methods, processes, and procedures.
- Cross-train on complex microbiology methods and/or multiple products.
- Author/revise technical documents (test methods, SOPs, specifications, trend reports, and/or sample plans) as appropriate.
Qualifications & Experience
- Bachelor’s degree or equivalent (preferably science); advanced degree preferred.
- 6+ years relevant microbiological testing or QC experience (preferably in a regulated environment).
- Demonstrated microbiological techniques.
- Ability to understand and apply Global Regulatory and cGMP requirements.
- Demonstrated technical writing skills.
Skills (Required/Preferred)
- Strong problem-solving, technical reasoning, and communication with peers and cross-functional partners.
- Ability to work in a fast-paced team, meet deadlines, and prioritize multiple projects.
- Preferred: advanced knowledge of LIMS/ELN and lab data analysis systems.
- Strong mentoring/coaching/influencing skills.