Lief Labs is a premier formulation and product development innovator and manufacturer of dietary supplements. Our in-house product development and R&D team creates the best-tasting and cutting-edge supplement formulations. Lief also houses a state-of-the-art, full-service Current Good Manufacturing Practice (cGMP) manufacturing facility, which offers custom solutions for many supplement categories. Lief collaborates with entrepreneurial firms to help them build premier brands. Our turnkey solutions allow us to engage in seamless partnerships that help brands with scalability and sustainable growth. Lief Labs is in the Santa Clarita Valley (Valencia, CA.)

Summary

The Microbiologist plays a crucial role in ensuring the safety and quality of nutraceutical products. This role is integral to ensuring the microbiological integrity of raw materials, finished products, packaging components, production environments, and processes. The ideal candidate brings strong technical expertise, deep understanding of regulatory requirements governing the dietary supplement industry, leadership capabilities within a GMP-compliant lab setting and must comply with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), ISO/IEC 17025, Laboratory Safety and any regulatory requirements. This role ensures product safety and quality by developing and executing validated microbiological methods, maintaining accurate documentation, and supporting regulatory and client audits.

Responsibilities

• Perform and oversee microbiological testing of all raw materials, in-process materials, finished products, and packaging components per FDA, USP, and internal specifications.
• Author, review, and revise Standard Operating Procedures (SOPs), validation protocols, test methods, and other controlled documents.
• Act as the microbiology subject matter expert (SME) during internal and external audits and inspections, including FDA and third-party.
• Oversee environmental monitoring programs and ensure compliance with regulatory and internal hygiene standards, including air, surface, water, and personnel monitoring, trend and report results.
• Support cross-functional teams including QA, Production, and R&D on contamination control strategies and microbiological risk assessments.
• Train and mentor junior microbiologists and lab technicians on methods, aseptic techniques, and compliance best practices.
• Maintain, calibrate, and troubleshoot microbiology laboratory equipment; ensure ongoing compliance with GLP, GMP, and audit readiness.
• Stay current on industry trends, emerging pathogens, and regulatory changes impacting microbiological testing in dietary supplements.
• Monitor and review outsourced microbiological test results; evaluate compliance and investigate discrepancies.
• Provide guidance on laboratory safety practices, including response to accidents and potential bloodborne pathogen exposure.
• Conduct and document cleaning and sanitization verification, including ATP and microbiological swabbing.
• Develop, validate, optimize, and implement microbiological methods and techniques as needed, including adoption of new or rapid microbiological methods.
• Evaluate and interpret complex data; identify trends and provide reports to management.
• Lead and document investigations into out-of-specification (OOS) or atypical results, including root cause analysis and CAPA.
• Participate in customer complaint investigations related to microbiological quality and provide supporting data.
• Provide microbiological expertise to support specification setting, client discussions, and regulatory compliance.
• Provide microbiology, sanitation, and GMP training to lab and production personnel; assist in competency checks for new hires.
• Ensure all data, records, and reports are maintained in compliance with GDP, traceability, and audit readiness requirements.
• Develop and support implementation of the facility cleaning and sanitization master plan.
• Participate in internal audits, supplier audits, and regulatory/client inspections.
• Provide regular updates to the QC Manager and escalate issues as needed.
• Perform additional duties as assigned.

Supervisory Responsibilities

No, supervising responsibilities

Minimum Qualifications

Education/Knowledge

Bachelor of Science or master’s degree in microbiology or a related scientific field

Experience:

• Minimum of 3 years of experience in a GMP-regulated microbiology laboratory, preferably within dietary supplements, pharmaceuticals, or food manufacturing.
• Strong knowledge of microbiological methods (USP <61>, <62>, <2021>, <2022>, etc.) and regulatory guidelines including 21 CFR Part 111 and 21 CFR Part 117.
• Proven ability to conduct method validation, lead investigations, and author technical reports.
• Proficient in laboratory documentation, data integrity principles, and use of LIMS or other digital systems.
• Hands-on experience with core microbiological testing methods (APC, Yeast & Mold, Coliforms, E. coli, S. aureus, Salmonella, etc.).
• Prior experience supporting regulatory inspections (FDA, NSF, UL, or equivalent).
• Excellent critical thinking, problem-solving, and decision-making skills.
• Effective communicator with ability to present complex scientific data to cross-functional stakeholders, both orally and in writing.
• Strong organizational and time management skills; able to manage multiple priorities and meet deadlines in a detail-oriented manner.
• Self-starter with the ability to work independently and collaboratively in a team environment.
• Committed to safety, compliance, and continuous improvement in laboratory practices.

Work Environment

The office is clean, orderly, properly lighted and ventilated. Noise levels are considered low to moderate. Field conditions vary.

Exposed to various raw materials, including allergens (i.e. milk, eggs, fish, shellfish, tree nut, peanuts, wheat, soy).

Physical Demands

While performing the duties of this job, the employee may regularly require talking, hear and grasp items. This position is active and requires standing, walking, bending, kneeling, stooping, crouching, crawling, and climbing all day.

Regularly exposed to moving mechanical parts, strong fumes, loud noises, and occasionally extreme temperatures

The employee must frequently grasp, lift and/or move items 10 pounds and occasionally grasp, lift and/or move items 33lbs.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Additional Information
The Hourly Range for this position at Lief Labs is $74,000.00 - $85,000.00/ annual (USD). Starting pay for the successful applicant depends on a variety of job-related factors, including but not limited to market demands, experience, training, skills, and education. The benefits available for this position include medical, dental, vision, 401(k) plan, life insurance coverage, wellness benefits, education reimbursement program, and PTO.

Lief is an Equal Opportunity employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, or sex, including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Suppose you are a qualified individual with a disability or a disabled veteran. In that case, you have the right to request accommodation if you are unable or limited in your ability to use or access our career center due to your disability. To request an accommodation, contact the Lief Human Resources department.

Lief will consider employment-qualified applicants with criminal histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring.

Lief uses E-Verify to confirm work eligibility in the United States. E-Verify compares the information on your Form I-9, Employment Eligibility Verification, to official government records.