Director of Microbiology

The client is seeking an onsite Director of Microbiology to lead a sterile injectable manufacturing site in sterility assurance and microbiology testing, while driving audit readiness and regulatory compliance. This role will oversee the microbiology function and support continuous quality improvement through strong compliance leadership and effective team management in a GMP environment. Key responsibilities include managing and supervising the microbiology team, overseeing microbiological testing activities (including environmental monitoring), sterility assurance, and media fills, and ensuring regulatory compliance. The director will also handle deviations and participate in CAPA and change control processes, and will be expected to contribute to audits and maintain direct communication with relevant regulatory bodies. Candidates will typically hold a Bachelor’s, Master’s, or PhD in a relevant field and bring extensive microbiology experience in GMP settings, including leadership experience in GMP sterile injectable environments. Additional qualifications expected include expertise in aseptic and sterility assurance, environmental monitoring program management, GMP/FDA regulatory compliance, and method development and validation. Legal authorization to work in the United States without employer sponsorship is required. Confidential