Associate Director, Environmental Monitoring Program Coordination

Bristol Myers Squibb seeks an Associate Director to establish and lead environmental monitoring governance across a global network of biologics and cell therapy manufacturing sites. The role involves developing harmonized standards, coordinating cross-site data trending, managing contamination control strategies, and serving as the primary subject matter expert for regulatory and operational inspections.

Responsibilities

• Establish global governance model and harmonized standards for environmental monitoring across manufacturing network
• Lead network-level data trending, cross-site comparison, and identification of systemic adverse signals
• Develop consistent global approach for trend evaluation, excursion categorization, and impact assessment
• Coordinate cross-site response to significant environmental monitoring excursions and contamination events
• Serve as global subject matter expert during deviation investigations, regulatory inspections, and facility qualification activities

Requirements

• Bachelor's degree in Microbiology, Biology, Biotechnology, Pharmaceutical Sciences, or related discipline
• 10+ years in biotechnology, biologics, sterile pharmaceutical, or cell therapy manufacturing
• Significant GMP environmental monitoring, QC microbiology, sterility assurance, or contamination control experience
• Demonstrated experience establishing or harmonizing monitoring programs across multiple sites or networks
• 5+ years of people leadership, program leadership, or cross-functional technical leadership in GMP environment
• Advanced degree preferred