Senior Manager, Sterility Assurance

About the Role

Working at Bristol Myers Squibb is challenging, meaningful, and life-changing. This role as Sr. Manager, Sterility Assurance is highly critical and supports the CAR T manufacturing site. You will manage Sterility Assurance, providing expertise in facility design/modifications, aseptic process validation, operator qualification/requalification, gowning certification, critical utilities sampling and testing, and the overall contamination control program. This position also requires acting as the Subject Matter Expert (SME) during regulatory inspections.

Responsibilities

• 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 operations.
• Ensure execution and support of the contamination control strategy, including aseptic process validation, facility design and modification, gowning, critical utilities, and Environmental Monitoring Performance Qualifications (EMPQs).
• Generate, own, and/or support change controls, deviations, and CAPAs within the eQMS system.
• Support equipment, facility, and microbiological method qualifications.
• Ensure site and department objectives are met.
• Manage and develop direct reports, including performance evaluations and career development.
• Onboard new materials required to support manufacturing operations.
• Support the manufacturing schedule and operational needs.
• Ensure employees are properly trained and qualified to perform assigned tasks.
• Gown for entry into the aseptic core and supporting areas as needed.
• Be on call to support manufacturing issues involving sampling and/or test excursions or questions during shift operations.
• Occasional travel may be required.
• Perform other tasks as assigned.

Requirements

• 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, etc.
• Advanced verbal and written communication skills.
• Demonstrated critical reasoning, problem-solving, troubleshooting, investigation, and decision-making skills.
• Team-oriented with the ability to work cross-departmentally throughout the manufacturing site.
• Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment.
• Advanced mentoring, coaching, influencing, negotiating, and personal interaction skills.
• Demonstrated resource management and planning skills.
• Flexible, adaptable, and 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.
• Proficiency in 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, etc.) preferred.
• Experience working with Quality Systems (SOPs, Change Control, Deviations, CAPAs, and Risk Assessments) preferred.

An equivalent combination of education and experience may substitute.

Pay

Summit West - NJ - US: $121,070 - $146,703 (full-time employee basis). Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate considers required skills, job location, work schedule, job-related knowledge, and experience. Final individual compensation will be based on demonstrated experience.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and 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, and survivor support.
• Work-life Benefits:
  • Paid Time Off for US Exempt Employees: Flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or Rayzebio).
  • Phoenix, AZ, Puerto Rico, and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
  • Additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year's Day.

All global employees (full and part-time) actively employed at and paid directly by BMS at the end of the calendar year are eligible for the Global Shutdown.