Microbiology Team Lead

Description

Role is responsible for managing microbiology laboratory operations across multiple product categories, including FDA OTC Drugs, Cosmetics, EPA Disinfectants, and other unregulated products. 

Requirements

Team Leadership and Management

• Lead, mentor, and develop a team of microbiologists across R&D and QC functions.

• Coordinate daily activities to ensure efficient use of resources and meet customer service requirements.

• Establish and execute plans consistent with development, manufacturing, and business needs.

Technical Oversight

• Provide microbiological expertise for manufacturing, production and R&D projects.

• Develops and maintains the safety protocols and criteria that are necessary for a BSL2 laboratory.

• Oversee environmental monitoring schedules, sampling, testing, and reporting.

• Ensure compliance with FDA, GMP, GLP, and ISO standards.

• Act as a subject matter expert for audit activities relating to microbiology.

• Completes hands-on testing as needed to support the laboratory.

• Expertise with USP methods and an ability to lead the development and validation of microbiological methods. 

Quality Assurance

• Implement and maintain quality control procedures for microbiology testing and ensure all samples are processed in a timely manner.

• Investigate out-of-specification (OOS) results and non-conformances.

• Creates, reviews and approve technical documents, including specifications and SOPs.

• Problem solves Customer related concerns and develops solutions.

Training and Development

• Develops and conduct training programs for staff on proper microbiological techniques, instrumentation, and procedures.

• Author and review SOPs for microbiology testing and quality control.

Research and Innovation

• Drive continuous improvement initiatives in microbiology testing methods.

• Collaborate with R&D teams on microbiology-related issues and new product development.

Regulatory Compliance

• Ensure adherence to regulatory requirements for FDA OTC Drugs, Cosmetics, EPA Disinfectants, and unregulated products.

• Stay current with industry standards and regulatory changes affecting microbiology testing.

Qualifications:

• Bachelor's degree in Microbiology, Biology, or related field; advanced degree preferred.

• Minimum 4 years of experience in QC Microbiology, with at least 2 years in a leadership role.

• Strong knowledge of microbiology techniques, including aseptic technique, environmental monitoring, and microbial identification.

• Experience with FDA OTC Drug, Cosmetic, and EPA Disinfectant regulations.

• Excellent communication and interpersonal skills.

• Proven ability to manage multiple projects and priorities in a fast-paced environment.

The ideal candidate will possess a combination of strong technical expertise, leadership skills, and regulatory knowledge to drive excellence in our microbiology operations across diverse product categories.

OTHER REQUIRED SKILLS

• Ability to lead or work within cross-functional teams
• Good verbal and written communication skills
• Ability to work well independently as well as in a group; cooperate with others.
• Able to work independently while maintain good communication with leadership
• Excellent time management and task prioritization abilities
• Strong work ethic, self-motivating
• Flexible; ability to multitask
• Detail-oriented/Focused

PHYSICAL REQUIREMENTS

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

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.

Equal Opportunity Employer