Microbiology Team Lead

Description

The Microbiology Team Lead serves as both a technical leader and a hands-on contributor for the microbiology team. This role balances day-to-day laboratory work with technical leadership responsibilities, ensuring both the quality and efficiency of the team’s output. This position is responsible for guiding the microbiological quality control testing of a diverse portfolio of products, including FDA over-the-counter (OTC) drugs, cosmetics, EPA-registered disinfectants, and other formulations. 

The ideal candidate will have hands-on experience conducting OTC efficacy testing, disinfectant efficacy studies, and preservative challenge tests in support of product development. The candidate should also be proficient in drafting and executing microbiological validation protocols and responding to FDA audits involving OTC drug products.

Requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

• Lead by example through active participation in microbiological testing, OTC efficacy studies, disinfectant efficacy studies, and preservative challenge tests in support of product development.
• Supervise, mentor and coach the team by training analysts in best practices, troubleshooting technical challenges, and fostering a culture of continuous learning and accountability.
• Ensure quality and compliance by reviewing microbiological data, records, and reports for accuracy; drafting and overseeing microbiological validation protocols; and supporting audit readiness, including direct interactions during FDA audits of OTC drug products.
• Own critical investigations by independently carrying out lab work when necessary, writing Out-of-Specification (OOS) reports, and leading root cause analyses while guiding the broader team through corrective and preventive actions (CAPAs).
• Ensure compliance with cGMP, GLP, and applicable ISO standards.
• Adhere to all microbiology-related Standard Operating Procedures (SOPs) and maintain accurate, detailed records of all testing activities.
• Develop and implement method validation and verification studies as required.
• Support internal and external audits, particularly those related to microbiology.
• Perform environmental monitoring of manufacturing areas, cleanrooms, and utilities.
• Recommend and implement improvements to manufacturing practices to enhance microbial hygiene.
• Execute microbial identification using various validated methods and technologies.
• Conduct preservative efficacy testing and antimicrobial effectiveness testing per United States Pharmacopeia (USP) standards.
• Participate in and support process improvement initiatives within the microbiology lab.
• Stay informed on industry trends, regulatory changes, and advancements in microbiological testing.

Microbiology-Specific Responsibilities:

• Apply aseptic techniques to ensure sterility during testing and monitor for potential contamination sources related to personnel or equipment.
• Conduct testing and documentation in alignment with applicable USP methods and procedures.
• Prepare culture media, reagents, and materials required for microbial testing.
• Perform microbial techniques including dilutions, culture propagation, isolation/purity plating, colony enumeration, Gram staining, and microbial screening.
• Maintain cryopreserved cultures for laboratory testing purposes.
• Write, review, and revise SOPs as required.
• Conduct weekly data reviews to ensure compliance with regulatory standards and internal quality expectations.

BEHAVIORAL CAPABILITIES:

Business Acumen: Knows how businesses work; knowledgeable in current and possible future policies, practices, trends and information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.

Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gain their trust and respect.

Integrity: Acts consistently with company values and the highest standards of ethical behavior.

Interpersonal Savvy: Relates well to all kinds of people, up, down, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.

Written/Verbal Communications: Is able to write & speak clearly and succinctly in a variety of communication settings and s