Senior Manager, QC Microbiology
Bristol Myers Squibb
6 months ago
On-site
Summit, NJ
Operations
Sr. Manager, QC Microbiology (R1596419)
Responsibilities:
- Manage QC Microbiology Laboratory supporting CAR T manufacturing; oversee microbiological testing of in-process samples, final product testing, critical utilities sampling/testing, validation & requalification support, incoming component testing, and microbiological identification.
- Coordinate and schedule the microbiology testing program to ensure timely results for release and disposition.
- Develop and manage SOPs, forms, and methods for compliant lab operations.
- Ensure materials/products/methods/equipment are within specifications; ensure accurate, timely disposition of test results and compliance investigations.
- Investigate OOS/OOT results exceeding specifications via Deviations in eQRM S system and implement effective CAPAs.
- Meet site/department objectives; manage and schedule laboratory personnel; ensure training/qualification, performance evaluations, and career development of direct reports.
Requirements / Qualifications:
- Advanced cGMP and regulatory knowledge (FDA, USP, MHRA, BP, EP, JP, PMDA, DEA) for cell therapy manufacture.
- Advanced data integrity; intermediate statistics (control charts, action/alert limits).
- Advanced microbiology knowledge (media, incubation, isolation, identification, enumeration) and intermediate validation/GEP knowledge (URS, IQ, OQ, PQ, PVs).
- Leadership/management and mentoring/coaching skills; strong communication; critical reasoning/problem-solving/investigation.
- Team-oriented; cross-departmental collaboration.
- Safety knowledge (OSHA/EPA, lockout/tagout, fall safety, HAZCOM, MSDS).
Education/Experience:
- Bachelor’s degree (preferably Microbiology or related); advanced degree preferred.
- 7 years relevant Quality experience (preferably microbiology lab/Environmental Monitoring); cell therapy experience preferred.
- 2–3 years leadership/managerial experience; experience supporting sterile compounding/filling or cell therapy.
Benefits/Compensation (as stated): $134,630–$163,142 (NJ). Health, wellbeing, 401(k), disability/life; paid time off; flexible time off/paid holidays.
Working Conditions:
- Office and microbiology lab environment; gowning for aseptic areas as needed; on-call to support manufacturing issues; occasional travel.
Responsibilities:
- Manage QC Microbiology Laboratory supporting CAR T manufacturing; oversee microbiological testing of in-process samples, final product testing, critical utilities sampling/testing, validation & requalification support, incoming component testing, and microbiological identification.
- Coordinate and schedule the microbiology testing program to ensure timely results for release and disposition.
- Develop and manage SOPs, forms, and methods for compliant lab operations.
- Ensure materials/products/methods/equipment are within specifications; ensure accurate, timely disposition of test results and compliance investigations.
- Investigate OOS/OOT results exceeding specifications via Deviations in eQRM S system and implement effective CAPAs.
- Meet site/department objectives; manage and schedule laboratory personnel; ensure training/qualification, performance evaluations, and career development of direct reports.
Requirements / Qualifications:
- Advanced cGMP and regulatory knowledge (FDA, USP, MHRA, BP, EP, JP, PMDA, DEA) for cell therapy manufacture.
- Advanced data integrity; intermediate statistics (control charts, action/alert limits).
- Advanced microbiology knowledge (media, incubation, isolation, identification, enumeration) and intermediate validation/GEP knowledge (URS, IQ, OQ, PQ, PVs).
- Leadership/management and mentoring/coaching skills; strong communication; critical reasoning/problem-solving/investigation.
- Team-oriented; cross-departmental collaboration.
- Safety knowledge (OSHA/EPA, lockout/tagout, fall safety, HAZCOM, MSDS).
Education/Experience:
- Bachelor’s degree (preferably Microbiology or related); advanced degree preferred.
- 7 years relevant Quality experience (preferably microbiology lab/Environmental Monitoring); cell therapy experience preferred.
- 2–3 years leadership/managerial experience; experience supporting sterile compounding/filling or cell therapy.
Benefits/Compensation (as stated): $134,630–$163,142 (NJ). Health, wellbeing, 401(k), disability/life; paid time off; flexible time off/paid holidays.
Working Conditions:
- Office and microbiology lab environment; gowning for aseptic areas as needed; on-call to support manufacturing issues; occasional travel.