Scientist, Sterility Assurance

Bristol Myers Squibb

Summit West, NJ, US
Base: $83,900 - $101,671; bonus/equity: + incentiv...
50% onsite
Cgmp and fda regulatory knowledge
Aseptic process validation expertise
Contamination control strategy management
The Scientist, Sterility Assurance provides critical support to the CAR T manufacturing site including facility design and aseptic process validation

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 options.

Matching Summary

The Scientist, Sterility Assurance provides critical support to the CAR T manufacturing site including facility design and aseptic process validation.

Salary

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

Skills & Requirements

Must-have

  • cGMP and FDA regulatory knowledge
  • Aseptic process validation expertise
  • Contamination control strategy management
  • Environmental monitoring trend analysis
  • SOP development and GMP compliance

Nice-to-have

  • Cell therapy product experience preferred
  • Regulatory audit support experience
  • Cross-departmental collaboration skills
  • Adaptability in high-pressure environments
  • Quality risk management program participation

Key Requirements

  • Bachelor's degree in Microbiology or related science
  • 3 years relevant work experience required
  • Experience with cell therapy products preferred
  • Knowledge of OSHA and EPA regulations
  • Proficiency in eQMS systems for change controls

Work Rights

Not specified

Tailored Resume

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