Senior Microbiology & Contamination Control Lead

Precigen; Germantown (MD); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

none

Job summary

Precigen seeks a Site Microbiologist to act as the microbiology and contamination control subject matter expert for the Germantown site, driving environmental monitoring, aseptic processing, and CCS governance across clinical and commercial manufacturing.

The role partners with Manufacturing, Quality Assurance, Engineering, Validation, and Regulatory Affairs to ensure compliance with global regulations, lead investigations, and push continuous improvements in microbiological methods, controls,

Qualifications

• Ph.D. or Master's Degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, Biotechnology, or related field.
• Minimum of ten years of experience in the pharmaceutical/biotech industry.
• Minimum of five years supporting sterile or aseptic manufacturing operations.
• Experience leading environmental monitoring and contamination control programs in GMP environments.
• Experience with regulatory inspections, audits, and CAPA processes.

Responsibilities

• Own and continuously improve the site's Contamination Control Strategy (CCS).
• Serve as the microbiology SME, lead governance and risk assessment reviews.
• Provide microbiological oversight for clinical and commercial manufacturing operations.
• Oversee environmental monitoring, EM reports, trends, and contamination control metrics.
• Lead microbiology-related investigations, root cause analyses, deviations, CAPAs, and quality system activities.
• Review cleaning/disinfection programs and disinfectant qualification data.
• Support qualification, validation, change control, tech transfer, and facility modifications.
• Collaborate with Manufacturing, QA, Engineering, Validation, and Regulatory Affairs for compliance and inspections.

Skills

Environmental monitoring

Aseptic processing

Leadership

Quality systems

Analytical troubleshooting

Education

Ph.D. in Microbiology

Master's degree in Microbiology

Job description

Precigen seeks a Site Microbiologist to act as the microbiology and contamination control subject matter expert for the Germantown site, driving environmental monitoring, aseptic processing, and CCS governance across clinical and commercial manufacturing.

The role partners with Manufacturing, Quality Assurance, Engineering, Validation, and Regulatory Affairs to ensure compliance with global regulations, lead investigations, and push continuous improvements in microbiological methods, controls,