Microbiology Lab Manager

Certified Group partners with customers to deliver innovative scientific solutions and expertise across the food & beverage, dietary supplements, cosmetics, OTC, tobacco/nicotine, cannabis, and hemp industries. Our network of 30+ North American and European laboratories includes specialized brands:

• Certified Laboratories – Comprehensive analytical and microbiological testing for food, beverage, cosmetics, OTC, and dietary supplements.
• Food Safety Net Services (FSNS) – ISO-accredited laboratories focused on food safety testing, operational support, and technical services.
• Labstat – Global leader in contract research and testing for nicotine, tobacco, cannabis, hemp, and next-generation products.
• EAS Consulting Group – Regulatory consulting firm offering expert guidance, training, and auditing support for FDA, USDA, and other regulated sectors.
• FSNS Certification & Audit – Accredited third-party auditing and certification services, including food safety, animal welfare, and GMP programs.

About the Role

The Microbiology Laboratory Manager oversees day-to-day operations of the Burbank Microbiology laboratory, ensuring accurate, compliant, and timely testing for local and national customers. The Burbank facility is GMP-registered and supports microbiological testing of OTC drug products, cosmetics/personal care products, antibiotic products, and sterility-related testing. The Manager is accountable for quality, customer, people, financial, and workflow activities within Microbiology, balancing scientific rigor and cGMP discipline with business acumen and continuous improvement. Key focus areas include 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.

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 proper resource utilization.
• Actively manage sample flow from receipt/intake and SME review through test start, incubation/reading, technical review, and result release; eliminate avoidable queue time.
• 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 to prevent procurement or readiness delays.

Quality & Safety

• Lead operations in accordance with cGMP requirements, Corporate Quality Management System, ISO/IEC 17025 (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 staff can explain processes, controls, investigations, and records.
• Partner with Quality and R&D/Validation on method suitability, verification, validation, transfer, deviations, and technical risk assessments.
• Ensure deviations, OOS/OOT results, laboratory investigations, CAPAs, and quality events are initiated promptly, scientifically sound, and completed within timelines.
• Maintain aseptic, contamination-control, environmental, cleaning/disinfection, and material-flow practices for sterility and sensitive microbiological activities.
• Monitor incubators, autoclaves, biosafety/clean-air equipment, environmental-monitoring devices, and other critical systems for qualification, calibration, maintenance, and readiness.

Customer Engagement

• Represent Certified Group with professionalism and care in all customer interactions, focusing on trust, retention, and growth.
• Ensure timely and accurate responses to customer questions about 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; ensure commitments reflect actual laboratory capacity and technical requirements.
• Participate in customer calls, investigations, technical reviews, audits, and business reviews; coordinate with Client Experience for consistent messaging.

People Leadership

• Anticipate staffing needs based on volume and test mix; design schedules across shifts, weekends, PET/sterility/stability activities, and customer commitments.
• Recruit, interview, select, onboard, train, and retain high-quality talent; maintain structured qualification and cross-training plans for methods, equipment, systems, and cGMP responsibilities.
• Coach supervisors and technical leads to create a high-performance environment with clear accountability for safety, quality, productivity, training, communication, attendance, and customer commitments.
• Reduce single-point dependencies by building technical depth across critical methods and shifts, including succession planning for supervisors, SMEs, and review functions.
• Maintain a visible daily presence in the laboratory to observe operations, reinforce standards, recognize performance, and provide real-time coaching.
• Partner with Human Resources on performance management and employee-relations matters, ensuring documentation is timely, thorough, and consistent.

Profitability

• Manage Microbiology financial performance by aligning labor, overtime, staffing, supplies, inventory, vendor costs, and operating plans with budget and laboratory contribution expectations.
• Use workload, productivity, utilization, backlog, and turnaround data to support staffing decisions and optimize resources before adding cost.
• Understand the cost of repeat testing, delayed starts, poor first-pass execution, excessive overtime, and customer escalations; implement corrective actions to improve service and profitability.
• Proactively manage outside vendors and service providers to minimize waste while maintaining quality and compliance standards.

Innovation and Continuous Improvement

• Contribute to cross-site best-practice sharing across the Certified Group network; support overflow testing, resource sharing, method transfer, and training.
• Use OTD, backlog, discrepancies, OOS/OOT, customer complaints, repeat work, and equipment downtime trends to prioritize and verify continuous-improvement actions.
• Identify opportunities for workflow redesign, standardization, scheduling improvements, LabWare enhancements, and automation to increase throughput without compromising quality or compliance.

Requirements

• Bachelor’s degree in Microbiology, Biology, Biological Sciences, or a closely related scientific field required; master’s degree preferred.
• Minimum five years of progressively responsible experience in a microbiology laboratory supporting GMP-regulated testing; experience in OTC/drug, pharmaceutical, cosmetics/personal care, antibiotic, or contract testing environments strongly preferred.
• Minimum three years of direct people-leadership experience; experience leading supervisors or technical leads who oversee hourly laboratory staff strongly preferred.
• Demonstrated experience with cGMP microbiology and compendial/validated methods, including microbial limits/enumeration, specified organisms, PET/AET, method suitability, growth promotion, sterility testing, and aseptic/environmental controls.
• Prior experience in a high-volume, customer-facing third-party laboratory strongly preferred, with demonstrated ability to manage OTD, backlog, capacity, customer escalations, and competing priorities.
• Working knowledge of laboratory investigations, deviations, CAPA, OOS/OOT, change control, audit readiness, training/qualification, and document control.
• Experience with LIMS-based laboratory operations required; LabWare experience preferred.
• Proven track record of using operational and financial KPIs to improve productivity, service, quality, and laboratory performance.
• Strong written and verbal communication skills, with the ability to interpret complex business, technical, quality, and regulatory documents.
• Confidence in presenting to and engaging with senior leadership, peers, customers, Quality, and cross-functional teams.

Skills

• Strategic Leadership: Align resources, capability, and capacity with Burbank and broader Certified Group objectives; anticipate risks before they impact customers or compliance.
• 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.