Microbiology Supervisor

The Microbiology Supervisor leads and develops the Microbiology Laboratory, expanding internal microbiological testing capabilities, managing third-party testing laboratories, and providing expert guidance on microbiological control within the production environment. This role ensures that products and manufacturing processes comply with microbial requirements, FDA regulations for OTC and cosmetic products, and internal policies and procedures, while supporting the launch and growth of new lotions, creams, and other water-based product lines.

• Lead, develop, document, and implement Microbiology Laboratory processes and programs to ensure products and the manufacturing environment meet all microbial requirements.
• Manage and lead the Microbiology Laboratory quality assurance (QA) and quality control (QC) programs, including direct oversight and development of one microbiology technician.
• Lead the development and execution of the Microbiology Laboratory research and development (R&D) program, including challenge studies, stability studies, and other testing for new water-based formulations and new manufacturing lines.
• Assess microbiological control within the manufacturing environment and proactively recommend process improvements to peers and leadership.
• Manage and coordinate internal microbiological testing and third-party testing laboratories to ensure accurate, timely, and compliant results.
• Report failing or out-of-specification (OOS) results to the QC Manager immediately and document each OOS in accordance with the Deviation/Investigation standard operating procedure (SOP).
• Format, analyze, and present microbiological data in a way that is appropriate for audiences with varying levels of technical knowledge.
• Execute tactical activities that support overall microbiology strategy and technical alignment with organizational goals.
• Ensure that all laboratory equipment remains in good operating condition, including scheduling and verifying calibration and routine maintenance.
• Lead the assessment, selection, purchase, and introduction of new laboratory equipment and instruments, including oversight of IQ/OQ/PQ activities.
• Ensure strict compliance with current Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP) across all microbiology operations.
• Support environmental monitoring programs, water system monitoring, cleaning validations, and in-process manufacturing support activities.
• Provide audit support by preparing documentation, responding to inquiries, and demonstrating compliance for internal and external audits.
• Contribute to documentation, planning, and audit readiness activities related to microbiology, quality, and R&D.
• Collaborate closely with production, quality, and R&D teams to support the successful scale-up and ongoing quality of new OTC and personal care product lines.

• Bachelors degree (BS/BA) in Microbiology or a closely related scientific discipline.
• 5+ years of experience in an FDA-regulated microbiology function, preferably supporting OTC or pharmaceutical products.
• Proven experience leading microbiology programs, including establishing and managing laboratory QA and QC activities.
• Demonstrated experience training and mentoring laboratory staff on microbiological techniques and technical functions.
• Hands‑on experience with microbiology laboratory operations, including bioburden testing and microbiology validation activities.
• Strong knowledge of environmental monitoring programs in a manufacturing or pharmaceutical setting.
• Familiarity with USP microbiology methods and standards, including USP microbiology validation.
• Ability to interpret and apply GMP, GLP, and GDP requirements in daily laboratory operations.
• Experience with audit support, including preparing documentation and responding to regulatory or customer audits.
• Strong analytical and data presentation skills, with the ability to tailor communication to both technical and non‑technical audiences.

• Experience working in cosmetics, pharmaceutical, or related regulated industries.
• Working knowledge of USP 61 and USP 62 testing requirements.
• Experience supporting water system monitoring, cleaning validation, and in-process manufacturing microbiology support.
• Experience in R&D support, including challenge testing, stability studies, and microbiological evaluation of new formulations.
• Demonstrated ability to lead the introduction of new…