Lief Labs is a premier formulation and product development innovator and manufacturer of dietary supplements. Our in-house Product Development and R&D team create the best-tasting and most cutting-edge formulations of supplements. Lief also houses a state-of-the-art, full-service Current Good Manufacturing Practice (cGMP) manufacturing facility, which offers custom solutions for a multitude of 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 located in the Santa Clarita Valley (Valencia, CA.)
Summary
We are seeking a highly skilled and experienced Microbiologist to join our team in a leading dietary supplement manufacturing environment. 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.
Key Responsibilities
Essential functions of the job are listed below. Other responsibilities may also be assigned. Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location. Reasonable accommodations may be made to allow differently abled individuals to perform the essential functions of the job.
- 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, external audits, inspections and product quality and safety related investigations.
- Oversee environmental monitoring programs and ensure compliance with regulatory and internal hygiene standards, including air, surface, water, and personnel monitoring, trend and report results.
- Create, execute, and document validation protocols for cleaning procedures, new equipment implementation, and process changes impacting environmental conditions, product quality, and product safety within a dietary supplement manufacturing environment.
- Collaborate cross-functionally with Quality, Manufacturing and Sanitation, teams to evaluate the microbiological impact of new processes, facility modifications, and equipment installations on controlled manufacturing environments and finished product safety.
- Perform validation activities including environmental monitoring assessments, equipment qualification support, cleaning verification, and risk evaluations to ensure compliance with 21 CFR Part 111, GMP requirements, and internal quality standards.
- 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 and all other activities related to product safety and quality strong technical experience.
- Provide regular updates to the QC Manager and escalate issues as needed.
- Perform additional duties as assigned.
Supervisory Responsibilities
None
Minimum Qualifications
The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position. Please note that the minimum qualifications may vary based upon the department size and/or geographic location.
Knowledge
Education:
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.
Skills / Abilities
- Exceptional communication, leadership, and team-building skills.
- Strong supervisory and leadership skills.
- Extensive knowledge of the principles, procedures, and best practices in the industry.
- Excellent organizational skills and attention to detail.
- Strong analytical and problem-solving skills.
- Proficient with Microsoft Office Suite or related software.
- Consultative, influential, strategic thinking and problem-solving skills
- Results-oriented in a fast-paced environment
- Ability to staff and develop a world-class engineering team to drive new programs
Physical Demands
In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.
While performing the duties of this job, the employee may regularly require to talk, hear and grasp items. This position is active and requires standing, walking, bending, kneeling, stooping, crouching, crawling, and climbing all day.
The employee must frequently grasp, lift and/or move items 10 pounds and occasionally grasp, lift and/or move items 20lbs.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Travel
None
Overall Work-Environment
In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the 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).
Additional Information
The Salary Range for this position at Lief Labs is $74,000 - 80,000 (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/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, 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.
If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request 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.
