Associate Director, Aseptic Operational Support

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