Job Description

Description

The Microbiology Team Lead is responsible for performing USP microbiological quality control testing on a range of products, including FDA-regulated over-the-counter (OTC) drugs, cosmetics, EPA-registered disinfectants, and unregulated formulations. This role establishes action and alert limits for microbial monitoring in accordance with FDA guidance and current industry standards and oversees the collection, testing, and documentation of environmental monitoring samples to ensure facility cleanliness and compliance. Additional responsibilities include preparation and maintenance of laboratory materials and equipment.

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. Regular duties include reviewing microbiological records for accuracy and regulatory compliance, as well as writing Out-of-Specification (OOS) reports and conducting root cause analyses.

Requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

• 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.
• Investigate and document Out-of-Specification (OOS) results and deviations, including root      cause analysis and corrective actions.
• Support internal and external audits, particularly those related to microbiology.
• Conduct microbiological testing on raw materials, in-process samples, and finished products.
• 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.
• Maintain a clean, organized, and safe laboratory environment.
• Ensure laboratory notebooks and electronic records comply with regulatory requirements.
• Participate in and support process improvement initiatives within the microbiology lab.
• Stay informed on industry trends, regulatory changes, and advancements in microbiological testing.
• Implement new methods and technologies as needed to remain compliant with current FDA standards.
• Perform daily procedures to ensure the laboratory is fully functional, including sanitization, equipment preparation, and material receipt.
  • Ensure laboratories are consistently clean and presentable for visitors and auditors.
• Ensure timely processing of all microbiological samples.
• Operate, maintain, and troubleshoot laboratory equipment as needed.
• Manage inventory of laboratory supplies, reagents, and culture collections.

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 styles; can get messages across that have the desired effect.

Negotiating: Can negotiate skillfully in tough situations with both internal and external groups; can settle differences with minimum noise; can negotiate with concessions without damaging relationships; can be both direct and forceful as well as diplomatic; gains trust quickly of other parties to the negotiations; has a good sense of timing.

Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.

Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very top-line oriented; steadfastly pushes self and others for results.

Leading Edge: Constantly benchmarks “best practices” and expects subordinates to do the same. Strives to be as leading edge as appropriate in light of costs.

Organization/Planning: Plans, organizes, schedules, and budgets in an efficient, productive manner. Focuses on key priorities. Effectively juggles multiple projects. Anticipates reasonable contingencies. Pays appropriate attention to detail.

EDUCATION and REQUIRED SKILLS:

• Bachelor’s degree in Microbiology, Biology, or a related scientific field; advanced degree preferred.
• 5–10 years of experience in Quality Control Microbiology, preferably within the pharmaceutical, cosmetic, or related regulated industries.
• 3–5 years of hands-on microbiology experience in a manufacturing environment.
• Strong proficiency in core microbiological techniques, including aseptic technique, microbial enumeration, and microbial identification methods.
• In-depth understanding of regulatory requirements and guidelines issued by the FDA, EPA, and other relevant agencies.
• Experience with hygienic manufacturing practices, including root cause analysis of microbial contamination and design of effective preservation systems.
• Demonstrated ability to write and execute validations for microbiological test methods.
• Ability to collect microbiological samples from manufacturing equipment, raw material containers, and bulk storage tanks.
• Exceptional attention to detail with strong analytical and problem-solving skills.
• Effective written and verbal communication skills.
• Proven ability to work both independently and collaboratively in a fast-paced, team-oriented environment.
• The ideal candidate will combine technical expertise in microbiology with a commitment to quality and regulatory compliance, supporting our team in maintaining the highest standards of product safety and efficacy.

PHYSICAL REQUIREMENTS:

• Must be able to stand for long periods at a time
• Must be able to life at least 50 pounds