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hims & hers

Microbiology Manager

hims & hers, New Albany, Ohio, United States, 43054

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Overview

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Microbiology Manager

role at

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

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, 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

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 PPE when handling these drugs (gloves, respiratory protection, gown, and other items as required).

Medical approval to wear respiratory protection may be required (negative/positive pressure respirators, including N95, full face respirator, SCBA, or PAPR).

Physical exertion is expected, including walking, standing, squatting, bending, and lifting up to 50 lbs as part of a twelve hour shift.

Given the risk of reproductive capability in handling certain Hazardous Drugs, associates must understand the potential risks.

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 applicable fair chance laws.

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 accommodations@forhims.com.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Research, Analyst, and Information Technology

Industries

Wellness and Fitness Services

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