Executive Director, Contamination Control & Microbiology

Regeneron Pharmaceuticals Inc.; New York (NY); On-site; USD 203,000 - 399,000; Full time

Job summary

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

This role ensures robust sterility assurance and microbial risk management, guiding cross-functional teams to align with global regulatory expectations. The Executive Director will steer environmental monitoring, EM trend analysis, and CAPA programs while maintaining current

Qualifications

• Bachelor’s degree in Microbiology, Molecular Biology, Biology, Pharmaceutical Sciences, or related field, with significant leadership in aseptic manufacturing environments.
• Extensive experience in contamination control, sterility assurance, and environmental monitoring.
• Strong knowledge of global regulatory expectations (EU Annex 1, FDA Aseptic Processing Guidance, USP, PIC/S).

Responsibilities

• Design, implement, and improve a holistic Contamination Control Strategy.
• Provide expert vision in environmental monitoring programs and cleanroom practices.
• Lead investigations and CAPAs for microbial excursions and sterility issues.
• Monitor program performance with EM trends, excursion rates, and media fill success rates.
• Apply QRM tools (FMEA, risk mapping) to contamination control decisions.
• Maintain current regulatory knowledge and translate into the program.
• Partner with QA Operations, Manufacturing, Facilities, and Microbiology Labs.
• Represent the contamination control program to regulators and partners.

Skills

Environmental monitoring

Aseptic processing

Root cause investigations

CAPA

Quality risk management

Leadership

Cross-functional collaboration

Regulatory interaction

Gowning practices

Education

Bachelor’s degree in Microbiology or related

Advanced degree preferred

Tools

Media fill

Job description

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

This role ensures robust sterility assurance and microbial risk management, guiding cross-functional teams to align with global regulatory expectations. The Executive Director will steer environmental monitoring, EM trend analysis, and CAPA programs while maintaining current