Microbiology Manager, Sterile (Pharmaceutical)

TL;DR

Microbiology Manager, Sterile (Pharmaceutical): Overseeing and executing the Environmental Monitoring (EM) Program in a sterile pharmaceutical compounding facility with an accent on sterility assurance and contamination control. Focus on managing microbial investigations, ensuring compliance with FDA 503A/503B and USP regulations, and coordinating with analytical laboratories.

Location: On-site in New Albany, Ohio

Company

hirify.global is a leading health and wellness platform redefining healthcare by providing affordable and personalized access to care.

What you will do

• Develop, manage, and optimize the facility’s Environmental Monitoring (EM) Program, including SOPs and validation.
• Define and maintain EM sampling plans for viable/non-viable air, surfaces, and personnel in ISO Class 5, 7, and 8 areas.
• Lead microbial investigations using root cause analysis (RCA) and implement CAPA to address excursions.
• Supervise personnel performing EM sampling and monitor compliance with aseptic techniques.
• Serve as the Subject Matter Expert (SME) and liaison for third-party laboratories and regulatory audits.
• Provide microbiological input on facility cleaning and disinfectant efficacy verification.

Requirements

• Bachelor’s degree or higher in Microbiology, Pharmacy, or a 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.
• Strong understanding of cGMP, USP <797>, <800>, <1116>, and FDA 503A/503B regulatory expectations.
• Ability to work on-site in New Albany, Ohio.
• Medical approval to wear respiratory protection (N95, PAPR, etc.) and ability to lift up to 50lbs.

Nice to have

• Prior experience managing an EM program from development through execution.
• Familiarity with viable and non-viable particle monitoring systems.
• Experience establishing new microbiology labs, including equipment and staffing.
• Experience supporting audits by FDA, BOP, or PCAB.

Culture & Benefits

• Competitive salary and equity compensation for full-time roles.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Comprehensive medical, dental, and vision insurance, plus parental leave.
• Employee Stock Purchase Program (ESPP) and 401k with employer matching.