Bristol Myers Squibb · 3 weeks ago
Senior Manager, Sterility Assurance
Summit, NJ
Full-time
Onsite
Mid, Senior Level
$121K/yr - $147K/yr
2+ years expBristol Myers Squibb is a company dedicated to transforming patients' lives through science. The Sr. Manager, Sterility Assurance is responsible for managing Sterility Assurance at the CAR T manufacturing site, ensuring compliance with contamination control strategies and supporting facility operations.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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
Qualification
Required
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-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
2-3 years of leadership/managerial experience required
Preferred
Experience working with cell therapy products is preferred
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
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.
Paid Time Off
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 employees)
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
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 Years Day.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-01-08
2026-01-07
2026-01-07
Company data provided by crunchbase