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.

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.

Hims & Hers is hiring a Microbiology Manager, Sterile