Senior Manager, Sterility Assurance

Bristol Myers Squibb

Summit West, NJ, United States
$121,070 - $146,703; not specified; not specified ...
50% onsite
Sterility assurance management
Aseptic process validation
Contamination control program
The Sr. Manager, Sterility Assurance is responsible for managing Sterility Assurance which provides support to the CAR T manufacturing site, including facility design, aseptic process validation, and contamination control

Job Summary

  • The Sr. Manager, Sterility Assurance is responsible for managing Sterility Assurance which provides support to the CAR T manufacturing site, including facility design, aseptic process validation, and contamination control.
  • Key responsibilities include supporting final product testing and release, managing SOPs, and acting as the SME during regulatory inspections.
  • Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals, both at work and in their personal lives.

Matching Summary

The Sr. Manager, Sterility Assurance is responsible for managing Sterility Assurance which provides support to the CAR T manufacturing site, including facility design, aseptic process validation, and contamination control.

Salary

$121,070 - $146,703; Not specified; Not specified

Skills & Requirements

Must-have

  • Sterility Assurance management
  • Aseptic process validation
  • Contamination control program
  • Regulatory inspections SME
  • cGMP, FDA, USP, MHRA, BP, EP, JP, PMDA, DEA regulations

Nice-to-have

  • Team-oriented and cross-departmental collaboration
  • Mentoring and coaching skills
  • Flexibility and adaptability
  • Experience with cell therapy products

Key Requirements

  • 2-3 years of leadership/managerial experience
  • Experience in participating and supporting regulatory audits
  • Experience in working with Quality Systems
  • Advanced knowledge of Microbiology
  • Advanced verbal and written communication skills

Work Rights

Not specified

Tailored Resume

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