Laboratory Manager

Tentamus California•Irvine, CA

1d•$90,000 - $110,000•Onsite

About The Position

Behind every reliable test result is a strong leader ensuring everything runs as it should. If you're ready to make that impact , we'd like to meet you! Tentamus California is on the prowl for a Laboratory Manager to join our team in Irvine, California. We're looking for a strong leader who can guide laboratory operations, support team development, and ensure consistent delivery of high-quality results in a regulated environment. WHAT YOU'LL DO As the Laboratory Manager, you will provide strategic, scientific, and operational leadership to ensure the successful delivery of high-quality, regulatory-compliant analytical testing services across a third-party GMP testing facility specializing in OTC products, raw material testing, in-process testing, finished product release, stability studies, method validation, and microbiological analysis. Reporting to the General Manager, your responsibilities include (but are not limited to): Leadership & Strategic Direction : Provide scientific and operational leadership across all departments (analytical chemistry, microbiology, stability, method validation, etc.); develop and execute long-term business and operational strategies aligned with company goals; determine long term plans for adding testing; lead, mentor, and develop supervisors, and provide them with the necessary support to complete their job; actively hire and recruit individuals; determine shift schedule for Chemistry department; ensure a culture of quality, safety, and regulatory compliance; report problems upwards as they happen to top management Regulatory Compliance & Quality Managemen t: Maintain full compliance with GMP, ISO 17025, FDA, USP, and other applicable regulatory standards; ensure readiness for client, regulatory, and accreditation audits and act as a primary point of contact for auditors; oversee and approve validation, verification, and qualification protocols for equipment, methods, and processes; collaborate with Quality Assurance to investigate out-of-specification (OOS) and out-of-trend (OOT) results and implement corrective/preventive actions (CAPAs); enforce the quality system and work with supervisors to keep compliance Operational Excellence & Laboratory Oversight : Oversee daily laboratory operations, scheduling, and resource allocation to meet client timelines; implement process improvements to optimize throughput, reduce turnaround times, and enhance data integrity; approve and oversee laboratory budgets, capital equipment purchases, and operational expenditures; ensure the laboratory's physical and IT infrastructure supports data security, accuracy, and traceability; manage LIMS as administrator and key problem solver; manage ECM as administrator and main point of contact for all problem solving and troubleshooting; review data to back up managers and supervisors; perform final review reports and release to clients; oversee equipment maintenance and compliance; validate and verify methods; ensure laboratory safety; manage ordering supplies; oversee training of staff; ensure lab cleanliness and organization; trend issues with the QA department; work through CAPA process and follow through on action items Client Relations & Business Development: Support business development efforts by providing technica l experti se during client meetings and proposal preparation ; mainta in strong client relationships and ensure customer satisfaction throug h time ly , high-quality deliverables; evaluate and expand laboratory capabilities to meet evolving client and market needs . SCHEDULE & POSITION This is a full-time, onsite role located at Tentamus California 133 Technology Dr #150, Irvine, CA 92618 . The schedule is M-F 9AM – 5PM with the occasional weekends . WHAT'S IN IT FOR YOU? Tentamus offers an annual salary between $90,000 - $110,000 , plus a comprehensive, low-cost, benefits package, including medical, dental, vision, disability, and life insurance. Employees also enjoy paid time off (PTO), 40 hours of sick time per California State Law, a matching 401k plan, and access to our free Employee Assistance Program ! QUALIFICATIONS The ideal candidate will be authorized to work in the United States indefinitely and without restrictions or sponsorship, hold a Bachelor's Degree in Chemistry, Microbiology, Biology, or related life science (Master's degree preferred) and/or with extensive experience in analytical laboratory testing will be considered; be a proactive, organized, and collaborative scientific leader who meets the following qualifications: Minimum 8-10 years of analytical chemistry laboratory experience in a regulated environment ( S upplements and Nutraceuticals testing , GMP, ISO, or similar), with at least 5 years in a leadership or management role . Strong knowledge of cGMP, USP, ISO/IEC 17025, and other applicable regulatory and quality standards, with a strong understanding of quality systems including deviations, OOS investigations, CAPA, and audit readiness Demonstrated experience managing laboratory operations, including workflow, staffing, and resource allocation, with proven ability to lead, coach, and develop high-performing technical teams Expertise in microbiological and/or analytical testing methods, instrumentation (HPLC), and laboratory techniques, along with experience using laboratory information management systems (LIMS) and other laboratory software . HPTLC experience is highly preferred. Excellent organizational, problem-solving, and decision-making skills with strong attention to detail, and the ability to manage multiple priorities in a fast-paced, high-pressure environment while maintaining accuracy and compliance Strong communication skills, both written and verbal, with the ability to collaborate cross-functionally and interface with clients Ability to work onsite full-time and maintain a flexible schedule, including extended hours or weekends as needed, and physical ability to perform laboratory duties, including lifting up to 50 lbs as Demonstrated commitment to safety, quality, compliance, and continuous improvement, with a professional, accountable, and team-oriented mindset and a strong sense of ownership and leadership presence ABOUT TENTAMUS: Labs for Life® . We are a global network of full-service accredited analytical laboratories providing crucial quality and safety analysis for clients locally, nationally, and beyond using proven methods of chemistry and microbiology. Many of the products you use and consume daily rely on Tentamus labs. With 20 labs in North America and growing (100 globally), we celebrate having talented diverse scientific and service-oriented professionals. Visit us at Tentamus.com | Follow Tentamus on LinkedIn | Follow Tentamus CA on LinkedIn

Requirements

Be authorized to work in the United States indefinitely and without restrictions or sponsorship
Hold a Bachelor's Degree in Chemistry, Microbiology, Biology, or related life science (Master's degree preferred) and/or with extensive experience in analytical laboratory testing will be considered
Be a proactive, organized, and collaborative scientific leader
Minimum 8-10 years of analytical chemistry laboratory experience in a regulated environment ( S upplements and Nutraceuticals testing , GMP, ISO, or similar), with at least 5 years in a leadership or management role
Strong knowledge of cGMP, USP, ISO/IEC 17025, and other applicable regulatory and quality standards, with a strong understanding of quality systems including deviations, OOS investigations, CAPA, and audit readiness
Demonstrated experience managing laboratory operations, including workflow, staffing, and resource allocation, with proven ability to lead, coach, and develop high-performing technical teams
Expertise in microbiological and/or analytical testing methods, instrumentation (HPLC), and laboratory techniques, along with experience using laboratory information management systems (LIMS) and other laboratory software
Excellent organizational, problem-solving, and decision-making skills with strong attention to detail, and the ability to manage multiple priorities in a fast-paced, high-pressure environment while maintaining accuracy and compliance
Strong communication skills, both written and verbal, with the ability to collaborate cross-functionally and interface with clients
Ability to work onsite full-time and maintain a flexible schedule, including extended hours or weekends as needed, and physical ability to perform laboratory duties, including lifting up to 50 lbs as
Demonstrated commitment to safety, quality, compliance, and continuous improvement, with a professional, accountable, and team-oriented mindset and a strong sense of ownership and leadership presence

Nice To Haves

HPTLC experience is highly preferred

Responsibilities

Provide scientific and operational leadership across all departments (analytical chemistry, microbiology, stability, method validation, etc.)
Develop and execute long-term business and operational strategies aligned with company goals
Determine long term plans for adding testing
Lead, mentor, and develop supervisors, and provide them with the necessary support to complete their job
Actively hire and recruit individuals
Determine shift schedule for Chemistry department
Ensure a culture of quality, safety, and regulatory compliance
Report problems upwards as they happen to top management
Maintain full compliance with GMP, ISO 17025, FDA, USP, and other applicable regulatory standards
Ensure readiness for client, regulatory, and accreditation audits and act as a primary point of contact for auditors
Oversee and approve validation, verification, and qualification protocols for equipment, methods, and processes
Collaborate with Quality Assurance to investigate out-of-specification (OOS) and out-of-trend (OOT) results and implement corrective/preventive actions (CAPAs)
Enforce the quality system and work with supervisors to keep compliance
Oversee daily laboratory operations, scheduling, and resource allocation to meet client timelines
Implement process improvements to optimize throughput, reduce turnaround times, and enhance data integrity
Approve and oversee laboratory budgets, capital equipment purchases, and operational expenditures
Ensure the laboratory's physical and IT infrastructure supports data security, accuracy, and traceability
Manage LIMS as administrator and key problem solver
Manage ECM as administrator and main point of contact for all problem solving and troubleshooting
Review data to back up managers and supervisors
Perform final review reports and release to clients
Oversee equipment maintenance and compliance
Validate and verify methods
Ensure laboratory safety
Manage ordering supplies
Oversee training of staff
Ensure lab cleanliness and organization
Trend issues with the QA department
Work through CAPA process and follow through on action items
Support business development efforts by providing technica l experti se during client meetings and proposal preparation
Mainta in strong client relationships and ensure customer satisfaction throug h time ly , high-quality deliverables
Evaluate and expand laboratory capabilities to meet evolving client and market needs