Senior Manager, QC Microbiology

Overview

Working with Us Challenging. Meaningful. Life-changing. Those words are often not associated with a job, but at Bristol Myers Squibb it is all possible. Here, uniquely interesting work happens every day, in every department, from optimizing a production line to breakthroughs in cell therapy. This is work that transforms the lives of patients and the careers of those who do it.

You’ll have opportunities to grow and thrive, alongside high-achieving teams. Take your career farther than you thought possible.

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At Bristol Myers Squibb we are reimagining the future of cell therapy. With bold ambition, a best-in-class team and long-term commitment, we aim to unlock the full promise of cell therapy and put more patients on the path to a cure. If you are ready to challenge yourself and accelerate your career, there’s no better place than here at BMS with our Cell Therapy team.

The Sr. Manager, QC Microbiology is a highly critical role responsible for managing the QC Microbiology Laboratory which provides support to the CAR T manufacturing site. This department handles microbiological testing of in-process samples, final product testing, critical utilities sampling and testing, validation and requalification support, incoming component testing, and microbiological identification. Sampling and testing must meet or exceed FDA, MHRA, PMDA, EU and other governmental regulations or guidelines.

The Sr. Manager QC Microbiology is responsible to act as the SME during regulatory inspections.

• Manage and coordinate the Microbiology Laboratory testing program and scheduling to ensure timely testing and results, supporting final product testing and release, incoming components and materials testing and release, and monitoring of critical utility systems.
• Develop and manage SOPs, forms, and methods required to support compliant operation and testing in the Microbiology laboratory.
• Ensure materials, products, methods, and equipment are within specifications and ensure accurate and timely disposition of test results and investigations.
• Submit any Microbiology lab test results that exceed specification limits as Deviations in the eQRM system, investigate, and implement effective CAPAs.
• Meet site and department objectives; manage Microbiology laboratory personnel to meet Manufacturing schedules and needs.
• Ensure employees are properly trained and qualified to perform assigned tasks, provide performance evaluations and support career development of direct reports.
• Perform other tasks as assigned.

• Bachelor’s degree required, preferably in Microbiology or related science. Advanced degree preferred.
• 7 years of relevant Quality work experience required, preferably in a Microbiology laboratory and/or Environmental Monitoring setting. Experience with cell therapy products is preferred.
• 2-3 years of leadership/management experience required.
• Experience in supporting sterile compounding, filling operations or cell therapy.
• Experience in participating and supporting regulatory audits (FDA, MHRA, PMDA, etc.).
• Experience with Quality Systems such as SOPs, Change Control, Deviations, CAPAs, and Risk Assessments.
• An equivalent combination of education and experience may substitute.

• The incumbent will work in an office and Microbiology laboratory environment and will need to gown for entry into aseptic core and supporting areas as needed.
• On-call to support manufacturing issues involving sampling or test excursions during shift operations.
• Occasional travel may be required.
• This description outlines the general nature and level of work; primary duties and responsibilities are considered essential.

The starting compensation range for this role is $134,630 – $163,142 (Summit West - NJ - US). Additional incentive cash and stock opportunities may be available. Final compensation will be based on demonstrated experience.

Eligibility…