Senior Director, Aseptic Process & Design Strategy
Bristol-Myers Squibb Co
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Benefits offered by this job
Job summary
Bristol Myers Squibb is seeking a senior leader for Aseptic Process & Design in New Jersey. You will own the enterprise aseptic process strategy, drive contamination control, and support regulatory inspections across global sites.
The role combines technical leadership with strategic oversight to ensure robust sterility assurance. Ideal candidates bring deep expertise in aseptic processing, risk management, and cross-functional leadership, with a proven track record in regulated GMP
Qualifications
- Bachelor's degree in Microbiology or related field required.
- 12+ years of progressive experience in pharmaceutical manufacturing, quality, sterility assurance, or microbiology in GMP environments.
- 7+ years of senior/leadership experience with direct accountability for sterile manufacture.
Responsibilities
- Lead microbial risk assessments and develop remediation action plans for internal sites.
- Provide authoritative review and sign-off on quality decisions impacting sterility across the network.
- Support regulatory inspections (FDA/EMA/PMDA) with expert testimony and documentation on aseptic processing.
- Drive CAPA development and effectiveness monitoring for systemic contamination trends.
Skills
Education
Tools
Job description
Bristol Myers Squibb is seeking a senior leader for Aseptic Process & Design in New Jersey. You will own the enterprise aseptic process strategy, drive contamination control, and support regulatory inspections across global sites.
The role combines technical leadership with strategic oversight to ensure robust sterility assurance. Ideal candidates bring deep expertise in aseptic processing, risk management, and cross-functional leadership, with a proven track record in regulated GMP
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