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