Sr. Director, Aseptic Process & Design

Bristol Myers Squibb · New Brunswick, NJ +5 more

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CMCFull-time$234k–$284kCompany career page

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Role summary

Senior Director role overseeing aseptic processing, sterility assurance, and contamination control strategy across Bristol Myers Squibb's global manufacturing network. Responsible for enterprise risk frameworks, regulatory compliance, and technical leadership on microbial control standards aligned with FDA and EMA requirements.

What they're looking for

Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or Chemical Engineering
12+ years progressive pharmaceutical manufacturing or quality experience in GMP environment
7+ years senior leadership experience with direct accountability for sterile manufacturing
Expertise in aseptic process design, environmental monitoring, and contamination control strategy
Deep knowledge of EU GMP Annex 1, FDA Aseptic Processing Guidance, ICH Q9/Q10/Q11 standards
Proficiency with risk management tools (FMEA, fault tree analysis, contamination control assessments)
Experience with Single-Use Technologies, biologics, or complex drug product manufacturing preferred

What you'll be doing

Define and maintain enterprise sterility failure mode library and contamination control taxonomy aligned with regulatory expectations
Perform global microbial risk assessments at internal sites and develop remediation action plans
Serve as escalation point for complex microbial and contamination quality events across facilities and equipment
Author technical Business Technical Assessments and provide expert testimony during regulatory inspections
Establish aseptic process simulation and media fill strategy, including program design and performance governance

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