Site Microbiology Lead: Contamination Control & EMS

Precigen, Inc; Germantown (MD); On-site; USD 140,000 - 170,000; Full time

Job summary

Precigen, Inc. in Germantown, MD is seeking a Site Microbiologist to lead contamination control and microbiology efforts for clinical and commercial manufacturing.

The role emphasizes governance of the CCS, environmental monitoring, and continuous improvement within a GMP-regulated setting. The Site Microbiologist will oversee aseptic processing, laboratory operations, and regulatory-aligned programs, collaborating across Manufacturing, QA, Engineering, and Validation to drive quality and

Qualifications

• Ph.D. or Master's Degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, Biotechnology, or a related scientific discipline.
• Minimum of ten years of experience in the pharmaceutical, biotechnology, biologics, cell therapy, or gene therapy industry.
• Minimum of five years of experience supporting sterile or aseptic manufacturing operations.

Responsibilities

• Own, maintain, and continuously improve the site’s Contamination Control Strategy (CCS).
• Provide microbiological oversight and routing floor support for clinical and commercial manufacturing operations, including assessment of aseptic processing practices.
• Lead or support microbiology-related investigations, root cause analyses, risk assessments, deviations, CAPAs, and quality system activities involving environmental monitoring excursions and contamination events.
• Partner with Manufacturing, QA, Engineering, Validation, and Regulatory Affairs to ensure compliance with regulatory requirements and best practices.

Skills

Environmental monitoring

Contamination control

Aseptic processing

Cross-functional leadership

Education

Ph.D. or Master

Job description

Precigen, Inc. in Germantown, MD is seeking a Site Microbiologist to lead contamination control and microbiology efforts for clinical and commercial manufacturing.

The role emphasizes governance of the CCS, environmental monitoring, and continuous improvement within a GMP-regulated setting. The Site Microbiologist will oversee aseptic processing, laboratory operations, and regulatory-aligned programs, collaborating across Manufacturing, QA, Engineering, and Validation to drive quality and