Microbiology Manager, Sterile

Microbiologist

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

About the Role:

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.

You Will:

• 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.

You Have:

• 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.

Preferred Qualifications:

• 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.

Our Benefits (there are more but here are some highlights):

• 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

Conditions of Employment:

• This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.

• This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).

• Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.

• Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at View email address on click.appcast.io and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.

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