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.
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, audits, and business reviews as needed; coordinate closely with Client Experience to present one consistent message.
People Leadership
- Anticipate staffing needs based on volume and test mix, and 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 and feedback.
- 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 that improve both service and profitability.
- Proactively manage outside vendors and service providers to minimize waste while maintaining appropriate quality and compliance standards.
Innovation and continuous improvement
- Actively contribute to cross‑site best‑practice sharing across the Certified Group network and support overflow testing, resource sharing, method transfer, and training where appropriate.
- 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 that increase throughput without compromising quality or compliance.
Qualifications:
- 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 several of the following: 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.
- Confident in presenting to and engaging with senior leadership, peers, customers, Quality, and cross‑functional teams.
Mathematical Skills:
- Work with mathematical concepts such as probability, statistical inference, trend analysis, and basic laboratory performance metrics.
- Apply concepts such as fractions, percentages, ratios, proportions, and basic financial measures to practical laboratory situations.
Supervision
- Lead Microbiology supervisors, technical leads, and/or designated staff and indirectly lead the broader Burbank Microbiology team; supervisory span may vary with business demand and organizational structure.
Physical Demands & Work Environment
- Potential exposure to odors, fumes, airborne particles, hazardous chemicals, disinfectants, and microbiological organisms/pathogens.
- Use of required PPE and controlled‑area/aseptic gowning where applicable.
- Noise level varies from quiet to loud and temperature may vary by laboratory area.
- The environment is interactive and fast‑paced, requiring frequent standing, walking, speaking, hearing, computer work, and use of hands.
- Occasionally lift and/or move up to 25 pounds.
- Night, weekend, or holiday work may be required based on customer demand, PET/sterility/stability schedules, audits, or laboratory events.
- Ability to travel occasionally as required.
Schedule: Monday‑Friday, 8:00AM-5:00PM
Salary Range for Pay Transparency
$100,000 — $135,000 USD
We are an Equal Opportunity Employer and make employment decisions without regard to protected characteristics under applicable law.