Manager, QC Microbiology, Cell Therapy

Bristol Myers Squibb seeks a Manager for QC Microbiology to oversee the microbiology laboratory supporting cell therapy manufacturing at the Devens site. The role manages testing operations, regulatory compliance, personnel, and quality systems while serving as subject matter expert during inspections.

Responsibilities

• Manage QC Microbiology department operations and personnel scheduling
• Develop and maintain standard operating procedures, methods, and quality documentation
• Oversee in-process and final product testing, incoming component testing, and utilities monitoring
• Investigate out-of-specification results and ensure effective corrective actions
• Train, evaluate, and develop direct reports while meeting site manufacturing objectives

Requirements

• Bachelor's degree in Microbiology or related science; advanced degree preferred
• 7 years relevant microbiology laboratory or environmental monitoring experience
• 2 years leadership experience preferred
• Experience supporting sterile compounding and filling operations
• Advanced knowledge of cGMP, FDA, USP, and international regulatory guidelines
• Advanced microbiology expertise including isolation, identification, and enumeration techniques
• Demonstrated ability to lead cross-functional teams and manage direct reports