Scientist, Sterility Assurance

Bristol Myers Squibb

Summit West, NJ, US
Base: $83,900 - $101,671; bonus/equity: + incentiv...
Hybrid (50% onsite)
Cgmp's, fda, usp, mhra, bp, ep, jp, pmda, dea regulations
Microbiology knowledge
Environmental monitoring
Bristol Myers Squibb is seeking a Scientist for Sterility Assurance at their Summit West, NJ facility, focusing on supporting CAR T manufacturing processes and ensuring compliance with regulatory standards. The ideal candidate will have a strong background in microbiology, experience in aseptic processes, and familiarity with regulatory audits

Job Summary

  • The Scientist, Sterility Assurance, provides support to the CAR T manufacturing site, including facility design/modifications, the aseptic process validation program, operator qualification, gowning certification, critical utilities, final product testing and adherence to the contamination control program for the site.
  • This role supports final product testing and release, incoming components and materials testing and release and monitoring of the critical utilities systems, and serves as Sterility Assurance SME for projects and continuous improvement initiatives.
  • Bristol Myers Squibb offers a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a Scientist for Sterility Assurance at their Summit West, NJ facility, focusing on supporting CAR T manufacturing processes and ensuring compliance with regulatory standards. The ideal candidate will have a strong background in microbiology, experience in aseptic processes, and familiarity with regulatory audits.

Salary

Base: $83,900 - $101,671; Bonus/Equity: Additional incentive cash and stock opportunities may be available; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits

Skills & Requirements

Must-have

  • cGMP's, FDA, USP, MHRA, BP, EP, JP, PMDA, DEA regulations
  • Microbiology knowledge
  • Environmental Monitoring
  • Contamination control strategy
  • Aseptic process validation

Nice-to-have

  • Cell therapy products experience
  • Regulatory audit support
  • Quality Systems experience
  • Team-oriented and cross-departmental collaboration
  • Flexible and adaptable under pressure

Key Requirements

  • Bachelor’s degree in Microbiology or related science
  • 3 years relevant work experience
  • Experience in Microbiology laboratory and/or Environmental Monitoring
  • Experience working with cell therapy products preferred
  • Experience in participating and supporting regulatory audits preferred
  • Experience in working with Quality Systems preferred

Work Rights

Not specified

Tailored Resume

Cover Letter