Microbiology Manager, Sterile

Requirements

• Develop, manage, and improve the facility's Environmental Monitoring (EM) Program, including SOPs, design, and program validation.
• Provide microbiological input on facility cleaning and disinfection programs, including disinfectant efficacy verification.
• Define and maintain EM sampling plans (viable air, non-viable air, surface, and compounding personnel sampling in ISO Class 5, 7, and 8 areas).
• Manage media qualification, incubation practices, and readings (interim and final).
• Perform or oversee microbial detection, CFU enumeration, growth assessment, and collaborate with labs for species identification.
• Maintain a microbial flora library and investigate excursions with data trending, RCA, and CAPA implementation.
• Train and supervise personnel performing EM sampling; monitor aseptic technique compliance.
• Maintain accurate, compliant EM records and reports.
• Serve as SME and liaison with third-party labs; support audits and inspections.
• Stay up to date with regulations, best practices, and technologies in microbiological testing and EM.

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution