HIMS Inc.
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
/ / , and cGMP requirements. You Will
Develop, manage, and improve the facilitys 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
Bachelors 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
,
,
, 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
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 are excited about this role, we encourage you to applyeven 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. 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 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 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 gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address. To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement. #J-18808-Ljbffr
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
/ / , and cGMP requirements. You Will
Develop, manage, and improve the facilitys 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
Bachelors 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
,
,
, 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
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 are excited about this role, we encourage you to applyeven 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. 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 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 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 gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address. To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement. #J-18808-Ljbffr