Microbiology Manager, Sterile

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. 

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.

We are seeking an experienced and detail-oriented Microbiologist with a strong background in aseptic processing environments and cleanroom operations. This role is essential for maintaining sterility assurance and contamination control programs in our sterile pharmaceutical compounding facility.

The Microbiology Manager will oversee and execute the Environmental Monitoring (EM) Program, lead microbial investigations, and act as the microbiology liaison with analytical laboratories. This role ensures all sampling and microbiological activities comply with 503A/503B regulations, USP <797>/<800>/<1116>, and cGMP 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.

• Bachelor’s degree or higher in Microbiology, Pharmacy, or related life science discipline.

• Minimum 5 years of direct experience in aseptic pharmaceutical, biotechnology, or compounding environments.

• Hands-on experience in ISO Class 5 (or better) cleanrooms, conducting microbiological assessments and contamination control.

• Strong understanding of cGMP, USP <797>, <800>, <1116>, and FDA 503A/503B regulatory expectations.

• Prior experience managing an EM program from development through execution.

• Familiarity with viable and non-viable particle monitoring systems, viable air samplers, surface sampling, and compounding personnel sampling.

• Experience using microbiology lab equipment and interpreting microbial identification results (gram stain, morphology, biochemical testing).

• Strong analytical and documentation skills; ability to work effectively in cross-functional teams.

• Experience establishing new microbiology labs (equipment, procedures, staffing).

• Experience supporting audits by FDA, BOP, or PCAB.