Executive Director, Contamination Control & Microbiology

Regeneron Pharmaceuticals, Inc; Town of East Greenbush (NY); On-site; USD 203,000 - 399,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc in East Greenbush, NY is seeking an Executive Director of QA Microbiology to lead the strategy, design and operational execution of the GMP contamination control program across aseptic and low-bioburden manufacturing sites.

You will guide environmental monitoring, sterile processing, and risk management, partner with QA Operations, Manufacturing and Facilities, and serve as the senior microbiology decision-maker with regulators and internal partners.

Qualifications

• Bachelor’s degree in Microbiology, Molecular Biology, Biology, Pharmaceutical Sciences, or related field (advanced degree preferred).
• Significant leadership experience in aseptic manufacturing environments.
• Deep operational expertise in aseptic processing and low-bioburden manufacturing.
• Strong knowledge of global regulatory expectations (EU Annex 1, FDA Aseptic Processing Guidance, USP <1116>, PIC/S).

Responsibilities

• Design, implement, and continuously improve a Contamination Control Strategy (CCS).
• Provide expert vision in environmental monitoring and aseptic processing performance.
• Influence root cause investigations and CAPA for microbial events.
• Monitor program performance with key metrics and drive continuous improvement.
• Embed Quality Risk Management tools within microbiology and aseptic operations.

Skills

Leadership

Microbiology

Regulatory knowledge

Environmental monitoring

GMP/ aseptic processing

Education

Bachelor's degree in Microbiology or related field

Advanced degree preferred

Job description

Regeneron Pharmaceuticals, Inc in East Greenbush, NY is seeking an Executive Director of QA Microbiology to lead the strategy, design and operational execution of the GMP contamination control program across aseptic and low-bioburden manufacturing sites.

You will guide environmental monitoring, sterile processing, and risk management, partner with QA Operations, Manufacturing and Facilities, and serve as the senior microbiology decision-maker with regulators and internal partners.