Role Overview
This position leads microbiological operations within a sterile pharmaceutical compounding facility, with primary responsibility for environmental monitoring, contamination control, and sterility assurance. The role ensures adherence to current Good Manufacturing Practices (cGMP), USP standards <797>, <800>, and <1116>, as well as FDA 503A and 503B regulatory requirements. As the designated microbiology subject matter expert, the individual collaborates closely with internal teams and external analytical laboratories.
Key Responsibilities
- Design, implement, and continuously improve the facility’s Environmental Monitoring (EM) program, including SOP development, validation, and sampling strategy
- Provide expert input on cleaning and disinfection protocols, including verification of disinfectant effectiveness
- Establish and maintain EM plans covering viable and non-viable air, surface, and personnel sampling across ISO Class 5, 7, and 8 environments
- Oversee media qualification, incubation procedures, and interpretation of microbial growth data
- Conduct or supervise microbial detection, colony-forming unit (CFU) counts, and growth evaluation, coordinating with labs for microbial identification
- Maintain a microbial flora database and lead investigations into monitoring excursions, including root cause analysis and corrective and preventive actions (CAPA)
- Train and supervise staff involved in EM activities, ensuring compliance with aseptic techniques
- Ensure accurate documentation and reporting of all microbiological data
- Serve as the primary contact for third-party laboratories and support readiness for regulatory audits and inspections
- Stay current with evolving microbiological testing methods, regulations, and industry best practices
Qualifications
A bachelor’s degree or higher in Microbiology, Pharmacy, or a related life science field is required. Candidates must have at least five years of hands-on experience in aseptic processing environments such as pharmaceutical compounding, biotechnology, or sterile manufacturing. Demonstrated expertise in cleanroom operations (ISO Class 5 or better), contamination control, and regulatory standards including cGMP, USP chapters, and FDA 503A/503B is essential.
Preferred candidates will have prior leadership in developing and managing EM programs, familiarity with particle and microbial monitoring systems, and experience with microbiological lab instrumentation and data interpretation. Strong analytical, documentation, and cross-functional collaboration skills are expected. Experience in setting up new microbiology laboratories and supporting regulatory audits (FDA, BOP, PCAB) is highly valued.
Work Environment
This is an onsite role requiring work with Hazardous Drugs (HD), necessitating the consistent use of Personal Protective Equipment (PPE). The position involves physical demands such as standing for extended periods (up to 100% of shift), walking (up to 50%), and lifting (up to 50 lbs.), with occasional bending and squatting. Shifts may extend up to twelve hours.
Compensation & Benefits
- Competitive salary with equity compensation
- Unlimited paid time off, company-recognized holidays, and quarterly mental health days
- Comprehensive medical, dental, and vision coverage
- Parental leave and Employee Stock Purchase Program (ESPP)
- 401(k) plan with employer matching
Company Commitment
The organization is dedicated to cultivating an inclusive, ethical workplace that values diverse perspectives and promotes employee wellness and belonging. A talent-first philosophy supports flexible and remote work arrangements where feasible. Applicants from all backgrounds are encouraged to apply, even if their experience does not perfectly align with every requirement.
All qualified applicants are considered without regard to any protected status, including disability or criminal history, in compliance with applicable fair chance hiring laws.
