Director of Microbiology (Irvine)

Director of Microbiology

Position Summary

CBS Butler

have partnered with a leading CDMO in Irvine, California who are looking for a

Director of Microbiology.

The

Director of Microbiology

will be responsible for the strategy and oversight of the Contamination Control Program within the manufacturing facility. This role leads Sterility Assurance, Environmental Monitoring, aseptic process oversight, and microbiological method validation while ensuring full cGMP compliance. The position provides technical leadership across manufacturing, quality, and regulatory functions and directs day-to-day microbiology laboratory operations.

Key Responsibilities Own and execute the Contamination Control Strategy across sterile manufacturing operations. Lead Sterility Assurance and Environmental Monitoring programs (media fills, sterility, endotoxin, bioburden, EM trending). Serve as SME for aseptic processing, investigations, change control, and CAPA. Direct microbiology laboratory operations, ensuring inspection readiness and regulatory compliance. Develop and lead laboratory staff, aseptic training, and qualification programs.

Qualifications 8+ years of progressive microbiology leadership experience in pharmaceutical or biotechnology manufacturing. Strong expertise in sterile drug product manufacturing and sterility investigations. Deep knowledge of global cGMP, FDA, EU, ICH, USP, EP, and Annex 1 requirements. Demonstrated leadership experience managing laboratory operations and cross-functional stakeholders. Bachelor’s degree or higher in Microbiology, Life Sciences, Chemistry, or related scientific discipline.