Associate Director, Aseptic Operational Support

$173.28k - $209.98k

Bristol Myers Squibb

Bristol Myers Squibb seeks an Associate Director of Aseptic Operational Support to provide technical oversight on facility and utility design, risk assessments, and quality governance across global manufacturing sites. The role ensures sterility assurance and microbial control requirements are integrated into facility design and regulatory compliance.

Responsibilities

Review and approve global risk assessments and quality impact assessments for contamination events and microbial control failures
Lead authorship of high-complexity business technical assessments supporting regulatory submissions and systemic issue resolution
Serve as global quality subject matter expert for aseptic facility and utility design, reviewing and approving design packages and qualification protocols
Define and maintain enterprise-level quality standards for aseptic facility design including cleanroom classification and critical utility systems
Provide technical oversight on facility modifications and technology transfers, ensuring contamination control strategies are integrated into design specifications

Requirements

Bachelor's degree in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or related scientific discipline
10+ years progressive experience in sterility assurance, aseptic manufacturing, microbiology, or pharmaceutical quality
At least 4 years in leadership or enterprise-level role
Deep expertise in aseptic processing, environmental monitoring, and contamination control in regulated manufacturing
Demonstrated experience authoring technical positions during FDA, EMA, and other regulatory inspections
Proven track record designing or overhauling aseptic process simulation or contamination control strategies at enterprise scale
Hands-on experience with sterilization validation and single-use system qualification

Apply

Vacancy posted 3 days ago

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