Laboratory Manager

Tentamus California • Irvine, CA

6d • $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 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
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 technical expertise during client meetings and proposal preparation; maintain strong client relationships and ensure customer satisfaction through timely, 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 required.

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 (Supplements 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 required
• 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 technical expertise during client meetings and proposal preparation
• Maintain strong client relationships and ensure customer satisfaction through timely, high-quality deliverables
• Evaluate and expand laboratory capabilities to meet evolving client and market needs

Benefits

• comprehensive, low-cost, benefits package, including medical, dental, vision, disability, and life insurance
• paid time off (PTO)
• 40 hours of sick time per California State Law
• a matching 401k plan
• access to our free Employee Assistance Program!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager