REQUIRED SKILLS

• Bachelor’s degree in Microbiology, Biology, or related field (Master’s preferred)
• Minimum 7 years of experience in microbiology within a GMP-regulated biologics or pharmaceutical manufacturing environment
• Minimum of 5 years of experience managing Quality Control laboratories, including oversight of method validation and method transfer activities
• Strong knowledge of aseptic processing, cleanroom classifications, and environmental monitoring programs
• Experience with regulatory inspections and audit readiness
• Proven leadership and team management skills
• Excellent communication, problem-solving, and organizational abilities

PREFERRED SKILLS

• Experience with biologics drug substance manufacturing (e.g., cell culture, fermentation, purification)
• Familiarity with rapid microbiological methods (RMM) and modern analytical technologies
• Experience developing contamination control strategies
• Experience managing projects
  Job Level: Management

ABOUT THIS ROLE

We are seeking a highly experienced and motivated Senior Microbiology Manager to lead the microbiology function at our state-of-the-art biologics drug substance manufacturing facility. This role is critical to ensuring the microbiological integrity of our processes, utilities, and environment, and plays a key role in supporting GMP compliance and product quality.

WHAT YOU’LL DO

• Lead and manage the site microbiology team, including hiring, training, and performance management
• Oversee environmental monitoring (EM), utility monitoring (WFI, clean steam, compressed gases), and microbiological testing of raw materials, in-process samples, and drug substance
• Develop and maintain microbiological control strategies for aseptic and non-aseptic manufacturing areas
• Provide technical leadership in contamination control, risk assessments, and deviation investigations
• Ensure compliance with global regulatory requirements (FDA, EMA, ICH, etc.) and internal quality standards
• Support regulatory inspections and audits as the subject matter expert (SME) for microbiology
• Drive continuous improvement initiatives in microbiological methods, EM programs, and contamination control
• Collaborate cross-functionally with Manufacturing, Quality Assurance, Validation, and Engineering teams