Senior Manager, Sterility Assurance

Bristol Myers Squibb

Base: $121,070 - $146,703; bonus/equity: + incenti...
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Advanced knowledge of cgmps and regulatory guidelines
Advanced knowledge of microbiology
Demonstrated leadership and management skills
** Bristol Myers Squibb is seeking a Senior Manager of Sterility Assurance to oversee contamination control strategies at their CAR T manufacturing site. The role requires extensive knowledge of regulatory compliance, microbiology, and leadership experience in a manufacturing environment. **

Job Summary

  • The Sr. Manager, Sterility Assurance is responsible for managing Sterility Assurance which provides support to the CAR T manufacturing site.
  • This role is responsible for supporting facility design/modifications, the aseptic process validation program, operator qualification/requalification, the gowning certification/recertification program, critical utilities sampling and testing, and overall contamination control program for the site.
  • Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer 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: 75

** Bristol Myers Squibb is seeking a Senior Manager of Sterility Assurance to oversee contamination control strategies at their CAR T manufacturing site. The role requires extensive knowledge of regulatory compliance, microbiology, and leadership experience in a manufacturing environment. **

Salary

Base: $121,070 - $146,703; 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

  • Advanced knowledge of cGMPs and regulatory guidelines
  • Advanced knowledge of Microbiology
  • Demonstrated leadership and management skills
  • Experience with Quality Systems (SOPs, Deviations, CAPAs)
  • Experience supporting regulatory audits

Nice-to-have

  • Experience working with cell therapy products
  • Team-oriented and cross-departmental collaboration

Key Requirements

  • 2-3 years of leadership/managerial experience
  • Advanced knowledge of cGMP's, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations
  • Advanced data integrity knowledge
  • Intermediate understanding of statistics
  • Intermediate knowledge of Good Engineering Practices and Validation Principles
  • Advanced verbal and written communication skills
  • Advanced knowledge of safety regulations

Work Rights

Not specified

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