Scientist, Sterility Assurance

Bristol Myers Squibb UK

Base: $83,900 - $101,671; bonus/equity: + incentiv...
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Cgmp and fda regulatory knowledge
Aseptic process validation execution
Contamination control strategy management
** Bristol Myers Squibb is seeking a Scientist for their Sterility Assurance team, focusing on supporting the CAR T manufacturing site. The ideal candidate will have experience in microbiology, regulatory compliance, and aseptic process validation, with a strong emphasis on working collaboratively in a dynamic environment. **

Job Summary

  • The Scientist, Sterility Assurance provides critical support to the CAR T manufacturing site including facility design and aseptic process validation.
  • This role requires acting as a Subject Matter Expert during regulatory inspections and responding to all regulatory inquiries in a timely manner.
  • Bristol Myers Squibb offers competitive benefits including health coverage, financial well-being programs, and flexible time off policies.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is seeking a Scientist for their Sterility Assurance team, focusing on supporting the CAR T manufacturing site. The ideal candidate will have experience in microbiology, regulatory compliance, and aseptic process validation, with a strong emphasis on working collaboratively in a dynamic environment. **

Salary

Base: $83,900 - $101,671; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Health, dental, vision, 401(k), paid time off

Skills & Requirements

Must-have

  • cGMP and FDA regulatory knowledge
  • Aseptic process validation execution
  • Contamination control strategy management
  • Environmental monitoring trend analysis
  • Regulatory inspection SME participation
  • SOP development and GMP compliance

Nice-to-have

  • Cell therapy product experience preferred
  • Cross-departmental collaboration skills
  • Critical reasoning and problem solving
  • Flexible and adaptable work style
  • Data integrity practices application

Key Requirements

  • Bachelor's degree in Microbiology or related science
  • 3 years relevant work experience required
  • Experience with cell therapy products preferred
  • Knowledge of FDA, MHRA, USP regulations
  • Experience with Quality Systems (SOPs, CAPAs)

Work Rights

Not specified

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