Director of Microbiology

The client is seeking an on-site Director of Microbiology to lead sterility assurance and microbiology testing at a sterile injectable manufacturing site. This role focuses on maintaining audit readiness and supporting regulatory compliance, with day-to-day oversight of microbiological testing activities and related quality systems. Key responsibilities include managing and supervising the microbiology team, overseeing microbiological testing, environmental monitoring (EM), sterility assurance, and media fills. The Director will ensure GMP/FDA regulatory compliance, manage deviations through appropriate corrective and preventive actions (CAPA), and administer change controls, while also participating in audits and communicating with regulatory bodies. Qualifications include a Bachelor’s, Master’s, or PhD in a relevant field and experience in a GMP environment, including recent GMP sterile injectable experience. Candidates are expected to have management experience, method development and validation experience, and strong expertise in aseptic and sterility assurance, contamination assessment, and environmental monitoring program management, along with the ability to lead and support compliance efforts. The client requires candidates to be legally authorized to work in the United States without current or future employer sponsorship.