Microbiology Lab Manager
Description
Certified Group is committed to partnering with customers to deliver innovative scientific solutions and expertise – So The World Can Trust In What It Consumes™. Our network of 30+ North American and European laboratories serves the food & beverage, dietary supplements, cosmetics, OTC, tobacco/nicotine, cannabis, and hemp industries.
Our Brands
Certified Group is comprised of a set of specialized brands that collectively deliver laboratory testing, regulatory consulting, and certification & audit services across highly regulated industries:
- Certified Laboratories – Provides comprehensive analytical and microbiological testing, primarily supporting food, beverage, cosmetics, OTC, and dietary supplement industries.
- Food Safety Net Services (FSNS) – A leading network of ISO-accredited laboratories across North America, focused on food safety testing, operational support, and technical services for the food industry.
- Labstat – A global leader in contract research and testing for nicotine, tobacco, cannabis, hemp, and next-generation products, with deep expertise in analytical chemistry and toxicology.
- EAS Consulting Group – A regulatory consulting firm offering expert guidance, training, and auditing support across FDA, USDA, and other regulated sectors, powered by a large network of independent advisors.
- FSNS Certification & Audit – Provides accredited third-party auditing and certification services, including food safety, animal welfare, and GMP programs.
Job Summary:
The Microbiology Laboratory Manager is responsible for the day-to-day operations of the Burbank Microbiology laboratory, ensuring accurate, compliant, and timely testing for the local and national customer base. Burbank is a GMP-registered facility supporting microbiological testing of OTC drug products, cosmetics/personal care products, antibiotic products, and sterility-related . The Manager is accountable for all quality, customer, people, financial, and workflow activities within Microbiology. The role operates with a strong general manager mindset, balancing scientific rigor and cGMP discipline with business acumen, resource optimization, customer engagement, and continuous improvement. Particular focus is required on on-time delivery (OTD), backlog control, timely PET/stability/sterility starts, method suitability readiness, and accurate execution in LabWare.
Purpose: So the world can trust in what it consumes.
Mission: Partner with customers to deliver innovative scientific solutions and expertise.
Values: start with the customer, commit to safety and quality, drive to deliver, act with integrity and support the team.
Leadership Accountabilities:
- Quality Excellence: Promote a culture where cGMP compliance, data integrity, technical accuracy, and adherence to approved methods and SOPs are embedded into every action. Ensure the laboratory remains audit- and inspection-ready.
- Customer-Focus: Ensure timely, high-quality results and proactive, factual communication on delays, study starts, technical concerns, and revised timelines to build trust and protect key customer relationships.
- People-Centricity: Maintain a safe, engaging, accountable environment. Be present and accessible, ensuring supervisors and analysts are trained, supported, cross-trained, and developed to perform at their best.
- Profitability: Manage labor, overtime, inventory, supplies, capacity, and other controllable costs while improving OTD, productivity, utilization, and sustainable laboratory contribution.
- Innovation: Drive continuous improvement through root-cause problem solving, standard work, LabWare workflow improvement, automation, and cross-site best-practice sharing.
Behavioral & Functional Competencies
- Strategic Leadership: Think beyond daily execution to align resources, capability, and capacity with Burbank and broader COS objectives; anticipate risks before they become customer or compliance issues.
- Quality Champion: Use sound microbiological and regulatory judgment to ensure work is technically defensible, methods are appropriate, and issues are escalated and corrected promptly.
- Customer Orientation: Build confidence through reliable commitments, transparency, responsiveness, and professional management of technical or service escalations.
- Team Empowerment: Develop supervisors, technical leads, and analysts; create clear accountability while building bench strength and reducing single-point dependencies.
- Operational & Financial Acumen: Use OTD, backlog aging, turnaround time, productivity, staffing, quality, and financial metrics to set priorities and make timely business decisions.
Responsibilities
Core Operations
- Foster a high-performing Microbiology laboratory environment aligned with Certified Group standards, Burbank cGMP expectations, and customer commitments.
- Lead daily operations using a balanced scorecard that includes OTD, backlog volume and aging, test starts, turnaround time, late work, staffing/capacity, quality events, and customer-critical commitments.
- Conduct daily huddles with supervisors and technical leads to set priorities, rebalance work, remove bottlenecks, and ensure available resources are properly utilized.
- Actively manage sample flow from receipt/intake and SME review through test start, incubation/reading, technical review, and result release; eliminate avoidable queue time between steps.
- Ensure timely initiation and execution of PET/AET, stability, sterility, microbial limits, specified-organism, suitability, growth-promotion, and other microbiological work within the site's approved scope.
- Maintain accurate and timely use of LabWare for Microbiology status, holds, scheduling, test initiation, result entry, and internal visibility.
- Maintain technical competence across the department and ensure sufficient SME coverage and cross-training for critical methods, shifts, and review functions.
- Proactively manage organisms, media, reagents, controls, sample quantities, and other prerequisites so procurement or readiness issues do not repeatedly delay testing.
Quality & Safety
- Lead operations in accordance with applicable cGMP requirements, the Corporate Quality Management System, ISO/IEC 17025 requirements where applicable, approved SOPs, validated/verified methods, and customer-specific requirements.
- Ensure the laboratory is inspection-ready for FDA, customer, accreditation, and internal audits. Be present during audits and ensure supervisors and SMEs can clearly explain their processes, controls, investigations, and records.
- Partner with Quality and R&D/Validation on method suitability, verification, validation, transfer, deviations, and technical risk assessments; testing must remain within the site's qualified and approved scope.
- Ensure deviations, OOS/OOT results, laboratory investigations, CAPAs, and quality events are initiated promptly, scientifically sound, and completed within established timelines.
- Maintain appropriate aseptic, contamination-control, environmental, cleaning/disinfection, and material-flow practices for sterility and other sensitive microbiological activities.
- Monitor incubators, autoclaves, biosafety/clean-air equipment, environmental-monitoring devices, and other critical systems to ensure qualification, calibration, maintenance, and readiness.
Customer Engagement
- Represent Certified Group with professionalism and care in all customer interactions, with a focus on trust, retention, and growth.
- Ensure timely and accurate responses to customer questions and concerns, especially around test suitability, study starts, delays, technical risk, and revised completion dates.
- Provide clear, factual, and consistent updates when results or study starts are at risk; avoid unsupported timelines and ensure commitments reflect actual laboratory capacity and technical requirements.
- Participate in customer calls, investigations, technical reviews,