Sr. Director, Aseptic Process & Design

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.

Responsibilities

• 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

Requirements

• 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