Bristol Myers Squibb · 1 day ago
Senior Manager, QC Microbiology
Summit, NJ
Full-time
Onsite
Senior Level
$135K/yr - $163K/yr
7+ years expBristol Myers Squibb is a leading company in the field of cell therapy, seeking to transform patients' lives through science. The Senior Manager, QC Microbiology is responsible for managing the QC Microbiology Laboratory, ensuring compliance with regulations and overseeing microbiological testing to support CAR T manufacturing.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Manage QC Microbiology department
Management and coordination of the Microbiological Laboratory testing program and scheduling to ensure timely testing and results, 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 and testing conducted in the Microbiology laboratory
The Senior Manager, QC Microbiology plays a critical role in ensuring that all materials, products, methods, and equipment are within specifications and ensuring accurate and timely disposition of test results and compliance investigations
Ensure that Microbiology lab test results which exceed the specification limits, are submitted as a Deviations in the eQRM system, investigated, and effective CAPAs are implemented
Ensure the site and department objectives are met
Management and scheduling of Microbiology laboratory personnel within the department to meet the 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
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
Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc
Intermediate knowledge of Good Engineering Practices and Validation Principles URS, IQ, OQ, PQ, PVs, etc
Ability to lead and maintain the development of Microbiology laboratory testing data and trending
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
Bachelor's degree required, preferably in Microbiology or related science
7 years' relevant Quality work experience required, preferably 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
Must have experience in supporting sterile compounding, filling operations or cell therapy
Preferred
Advanced degree 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
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
MedCity News
2026-01-06
Dallas Morning News
2026-01-05
2025-12-30
Company data provided by crunchbase