Senior Manager, Sterility Assurance

Position Summary

The Sr. Manager, Sterility Assurance, is a highly critical role responsible for managing Sterility Assurance to support the CAR T manufacturing site. The role oversees facility design and modifications, the aseptic process validation program, operator qualification/requalification, gowning certification/recertification program, critical utilities sampling and testing, and the overall contamination control program for the site. The Sr. Manager Sterility Assurance also serves as the subject‑matter expert during regulatory inspections.

• Support final product testing and release, incoming components and materials testing and release, and monitoring of critical utilities systems.
• Develop and manage SOPs, forms, and methods required to support compliant operation.
• Ensure execution and support of the contamination control strategy for the facility, including aseptic process validation, facility design and modification, gowning, critical utilities, and EMPQs.
• Generate, own, and/or support change controls, deviations, CAPAs within the eQMS system.
• Support equipment, facility, and microbiological method qualifications.
• Ensure site and department objectives are met.
• Manage and develop direct reports, onboard new materials required to support manufacturing operations, and support manufacturing schedule and needs.
• Ensure employees are properly trained and qualified to perform assigned tasks, provide performance evaluations, and support career development of direct reports.
• Required to gown for entry into the aseptic core and supporting areas on an as‑needed basis.
• Expected to be on call to support manufacturing issues involving sampling and/or test excursions or questions during shift operations.

• Advanced knowledge of cGMPs, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines related to the manufacture of cell therapy products.
• Advanced data integrity knowledge and practices.
• Intermediate understanding of statistics, control charts, action and alert limits, and data trending.
• Advanced knowledge of Microbiology.
• Intermediate knowledge of Good Engineering Practices and Validation Principles (URS, IQ, OQ, PQ, PVs).
• Advanced verbal and written communication skills.
• Demonstrated critical reasoning, problem‑solving, troubleshooting, investigation, and decision‑making skills.
• Team‑oriented with demonstrated ability to work cross‑departmentally throughout the manufacturing site.
• Demonstrated leadership and management skills, including establishing direction and goals, guiding execution while fostering a team‑based environment.
• Advanced mentoring, coaching, influencing, negotiating, and personal interaction skills.
• Demonstrated resource management and planning skills.
• Flexibility and adaptability, able to work under pressure while meeting designated timelines.
• Advanced knowledge of safety, OSHA, and EPA regulations, electrical and energized equipment (lockout/tag‑out), fall safety, HAZCOM, MSDS sheets, etc.
• Advanced proficiency with Microsoft Word, Outlook, Excel, PowerPoint, etc.
• Experience in a microbiology laboratory and/or environmental monitoring setting.
• Experience working with cell therapy products is preferred.
• 2‑3 years of leadership/managerial experience required.
• Experience in participating and supporting regulatory audits (FDA, MHRA, PMDA) preferred.
• Experience working with Quality Systems (SOPs, Change Control, Deviations, CAPAs, and Risk Assessments) preferred.
• An equivalent combination of education and experience may substitute.

Summit West - NJ - US: $121,070 - $146,703 (starting compensation range for a full‑time employee). Additional incentive cash and stock opportunities (based on eligibility) may be available. Final, individual compensation will be decided based on demonstrated experience.

• Health Coverage:
  Medical, pharmacy, dental and vision care.
• Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Programs (EAP).
• Financial Well‑being & Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, survivor support.
• Paid Time Off:
  Unlimited flexible time off (with manager approval) and 11 paid national holidays; additional vacation, sick, volunteer days and flexibility options per eligibility.
• Global Shutdown:
  Annual Global Shutdown between Christmas and New Years Day for all eligible employees.
• Summer Hours Program:
  Optional hours flexible, leaves of absence for medical, personal, parental, caregiver, bereavement and military needs.

Bristol Myers Squibb is an equal‑opportunity employer. If you believe that this job posting is missing information required by local law or is otherwise incorrect, contact BMS at  For a complete Equal Employment Opportunity statement, visit our career site.