Microbiology Lab Manager

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:

1. 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.
2. 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.
3. 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.
4. Profitability: Manage labor, overtime, inventory, supplies, capacity, and other controllable costs while improving OTD, productivity, utilization, and sustainable laboratory contribution.
5. Innovation: Drive continuous improvement through root-cause problem solving, standard work, LabWare workflow improvement, automation, and cross-site best-practice sharing.

Behavioral & Functional Competencies:

1. 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.
2. Quality Champion: Use sound microbiological and regulatory judgment to ensure work is technically defensible, methods are appropriate, and issues are escalated and corrected promptly.
3. Customer Orientation: Build confidence through reliable commitments, transparency, responsiveness, and professional management of technical or service escalations.
4. Team Empowerment: Develop supervisors, technical leads, and analysts; create clear accountability while building bench strength and reducing single-point dependencies.
5. 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

The compensation details provided below reflect the expected pay range for this role, based on the selected compensation structure and applicable guidelines. Actual pay within this range may vary depending on factors such as experience, skills, qualifications, and geographic