Executive Director, QA Microbiology & Contamination Control

Regeneron Pharmaceuticals, Inc.; Town of East Greenbush (NY); On-site; USD 200,000 - 350,000; Full time

Job summary

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

You will guide environmental monitoring, sterility assurance, and microbial risk management to ensure patient safety and regulatory compliance. You will influence investigations, drive continuous improvement with robust metrics, and partner with QA Operations,

Qualifications

• Bachelor’s degree in Microbiology, Molecular Biology, Biology, Pharmaceutical Sciences, or related scientific discipline (advanced degree preferred).
• Progressive experience in pharmaceutical/biopharmaceutical microbiology, sterility assurance, or contamination control with significant leadership in aseptic environments.
• Deep operational expertise in aseptic processing and low-bioburden manufacturing, including cleanroom design and HVAC principles.
• Hands-on ownership of a Contamination Control Strategy (CCS) with EM design, monitoring, trending, and risk-based site selection.

Responsibilities

• Design, implement, and continuously improve a holistic Contamination Control Strategy (CCS) grounded in microbiology and aseptic processing principles.
• Provide expert vision in environmental monitoring programs, cleanroom classification, gowning practices, and media fill performance.
• Influence root cause investigations and risk assessments for microbial excursions and environmental monitoring deviations with science-based CAPAs.
• Monitor CCS performance using EM trends, excursion rates, and media fill success metrics.
• Embed QRM tools within microbiology and aseptic operations to proactively identify contamination vectors.

Skills

Leadership in aseptic manufacturing

Environmental monitoring programs

Gowning and sterility practices

Quality risk management

Education

Bachelor’s degree in Microbiology or related science (advanced degree preferred)

Job description

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

You will guide environmental monitoring, sterility assurance, and microbial risk management to ensure patient safety and regulatory compliance. You will influence investigations, drive continuous improvement with robust metrics, and partner with QA Operations,