Executive Director, Contamination Control & Microbiology

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

Benefits offered by this job

Annual bonuses

Equity awards

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron 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 facilities. You will provide technical direction for sterility assurance and microbial risk management, influencing multiple functional areas.

This senior role partners with QA Operations, Manufacturing, Facilities/Engineering, and Microbiology Labs to translate strategy into robust on-the-floor execution and to

Qualifications

• Advanced degree and extensive experience in pharmaceutical/biopharmaceutical microbiology, sterility assurance, or contamination control.
• Strong leadership in aseptic manufacturing environments and a proven track record with CAPA and deviation management.
• Experience representing microbiology/contamination control to health authorities during inspections.

Responsibilities

• Design, implement, and improve a holistic Contamination Control Strategy (CCS).
• Provide expert vision in environmental monitoring, cleanroom classification, and gowning practices.
• Lead investigations and risk assessments for microbial excursions and sterility failures.
• Embed quality risk management tools to mitigate contamination vectors across sites.
• Translate strategy into floor-level, compliant aseptic practices.

Skills

Aseptic manufacturing

Regulatory knowledge

Risk management

Leadership

Education

Bachelor's in Microbiology

Advanced degree preferred

Tools

Environmental Monitoring Design

Aseptic Process Simulation

GMP compliance tooling

Job description

Regeneron 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 facilities. You will provide technical direction for sterility assurance and microbial risk management, influencing multiple functional areas.

This senior role partners with QA Operations, Manufacturing, Facilities/Engineering, and Microbiology Labs to translate strategy into robust on-the-floor execution and to