Senior Manager, Sterility Assurance

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

The Sr. Manager, Sterility Assurance, is a highly critical role and is responsible for managing Sterility Assurance which provides support to the CAR T manufacturing site. This role is responsible for supporting facility design/modifications, the aseptic process validation program, operator qualification/requalification, the gowning certification/recertification program, critical utilities sampling and testing, and overall contamination control program for the site. The Sr. Manager Sterility Assurance is responsible to act as the SME during regulatory inspections.

Duties/Responsibilities

• To support final product testing and release, incoming components and materials testing and release and monitoring of the critical utilities systems.

• Development and management of SOPs, forms, and methods required to support the compliant operation.

• The Senior Manager, Sterility Assurance plays a critical role in ensuring the execution and support of the contamination control strategy for the facility including, but not limited to aseptic process validation, facility design and modification, gowning, critical utilities, and EMPQs. Generates, owns, and/or supports change controls, deviations, CAPAs within the eQMS system.

• Support equipment, facility, and microbiological method qualifications.

• Ensure the site and department objectives are met.

• Manage and develop direct reports.

• Onboard new materials required to support manufacturing operations.

• 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.

• The incumbent will be required to gown for entry into Aseptic core and supporting areas, on an as-needed basis.

• The management incumbent (or designee) will be expected to be on call, to support manufacturing issues involving sampling and/or test excursions or questions during shift operations.

• This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.

• The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

• Occasional travel may be required.

• Perform other tasks as assigned.

Qualifications

• Advanced knowledge of cGMP's, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines, as related to 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.

• Must be team-oriented and has the demonstrated ability to work cross[1]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 and coaching, influencing, negotiating and personal interaction skills.

• Demonstrated resource management and planning skills.

• Must be flexible and 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.

• Advanced of Microsoft Word, Outlook, Excel, PowerPoint, etc.

• 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 preferred: FDA, MHRA, PMDA, etc.

• Experience in working with Quality Systems preferred: SOPs, Change Control, Deviations, CAPAs, and Risk Assessments.

•  An equivalent combination of education and experience may substitute

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Summit West - NJ - US: $121,070 - $146,703

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only:  If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [email protected]with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1596592 : Senior Manager, Sterility Assurance