Site Microbiologist Lead – Contamination Control

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

Benefits offered by this job

Job summary

Precigen, Inc. is seeking a Site Microbiologist in Germantown, MD to lead the contamination control program across clinical and commercial manufacturing.

You will oversee environmental monitoring, aseptic processing, cleanroom qualification, and microbiological investigations while partnering with Manufacturing, QA, Engineering, and Regulatory Affairs to ensure GMP compliance. The role emphasizes continuous improvement of CCS, microbial methods, and data-driven risk management to maintain

Qualifications

• Ph.D. or Master's degree in microbiology, biological sciences, pharmaceutical sciences, biotechnology or related field.
• Minimum of ten (10) years in pharma/biotech/biologics/gene therapy industries.
• Minimum of five (5) years supporting sterile or aseptic manufacturing operations.
• Experience leading environmental monitoring, CCS and contamination control programs in GMP environments.
• Knowledge of cGMP, FDA/EU/ICH regulatory requirements with regulatory inspection experience.

Responsibilities

• Own and continuously improve the Contamination Control Strategy (CCS).
• Provide microbiology oversight for environmental monitoring and EM programs.
• Lead microbiology-related investigations, CAPAs, and risk assessments.
• Collaborate with Manufacturing, QA, Engineering, Validation, and Regulatory Affairs.
• Drive continuous improvement of microbiological methods and laboratory processes.

Skills

Environmental monitoring

Aseptic processing

Contamination control

GMP compliance

Microbiological investigations

Education

Ph.D. or Master's Degree in Microbiology or related field

Job description

Precigen, Inc. is seeking a Site Microbiologist in Germantown, MD to lead the contamination control program across clinical and commercial manufacturing.

You will oversee environmental monitoring, aseptic processing, cleanroom qualification, and microbiological investigations while partnering with Manufacturing, QA, Engineering, and Regulatory Affairs to ensure GMP compliance. The role emphasizes continuous improvement of CCS, microbial methods, and data-driven risk management to maintain