Advanced understanding of microbiology and aseptic processing
Experience with em/cu monitoring program development
Knowledge of us and eu cgmp regulations
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Bristol Myers Squibb is seeking a Manager of Sterility Assurance to oversee compliance with contamination control programs at their Devens, MA facility. The role involves collaboration across functions to ensure adherence to regulatory standards and continuous improvement in sterility assurance systems.
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Job Summary
This role is responsible for overseeing the site contamination control program and ensuring compliance with FDA, EMA, and USP regulations.
The position requires acting as a Subject Matter Expert for projects, continuous improvement initiatives, and Quality Risk Management programs within sterility assurance.
Bristol Myers Squibb offers competitive benefits including health coverage, financial well-being plans, and flexible time off options.
Matching Summary
Match Score: 75
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Bristol Myers Squibb is seeking a Manager of Sterility Assurance to oversee compliance with contamination control programs at their Devens, MA facility. The role involves collaboration across functions to ensure adherence to regulatory standards and continuous improvement in sterility assurance systems.
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Salary
Base: $100,480 - $121,756; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), paid time off
Skills & Requirements
Must-have
Advanced understanding of Microbiology and aseptic processing
Experience with EM/CU monitoring program development
Knowledge of US and EU cGMP regulations
Proficiency with quality management systems and CAPAs
Minimum 6 years experience in cGMP environment
Nice-to-have
Knowledge of cell therapy manufacturing
Experience with internal and regulatory inspections
Strong critical reasoning and problem-solving skills
Ability to work cross-functionally under pressure
Key Requirements
Bachelor's degree in STEM field preferred
Minimum 6 years' experience in cGMP environments
At least 3 years' experience in QC Microbiology or sterility assurance
Must maintain gowning qualification for aseptic processing areas