Senior Manager, Sterility Assurance

Bristol Myers Squibb

Summit West, NJ, US
Base: $121,070 - $146,703; bonus/equity: + incenti...
50% onsite
Advanced knowledge of cgmp regulations
Microbiology laboratory experience
Aseptic process validation management
The Senior Manager, Sterility Assurance is a critical role responsible for managing sterility assurance support for the CAR T manufacturing site

Job Summary

  • The Senior Manager, Sterility Assurance is a critical role responsible for managing sterility assurance support for the CAR T manufacturing site.
  • This position requires acting as a Subject Matter Expert during regulatory inspections from agencies such as the FDA, MHRA, and PMDA.
  • Bristol Myers Squibb offers competitive benefits including health coverage, financial well-being programs, and flexible time off options.

Matching Summary

The Senior Manager, Sterility Assurance is a critical role responsible for managing sterility assurance support for the CAR T manufacturing site.

Salary

Base: $121,070 - $146,703; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Health, dental, vision, 401(k), paid time off, and wellbeing support

Skills & Requirements

Must-have

  • Advanced knowledge of cGMP regulations
  • Microbiology laboratory experience
  • Aseptic process validation management
  • Contamination control strategy execution
  • Regulatory inspection SME capability

Nice-to-have

  • Experience with cell therapy products
  • Cross-departmental collaboration skills
  • Leadership and mentoring abilities
  • Flexible and adaptable work style

Key Requirements

  • 2-3 years of leadership/managerial experience required
  • Advanced knowledge of cGMP, FDA, USP, and other global regulations
  • Experience in Quality Systems (SOPs, Change Control, CAPAs)
  • Intermediate understanding of statistics and data trending

Work Rights

Not specified

Tailored Resume

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