Lab Supervisor, Microbiology

Position Summary

This position is responsible for leading a team of lab analysts to execute testing in support of environmental monitoring and microbiological control programs. This role will manage the day-to-day activities to ensure cGMP compliance, data integrity, safety, and right first-time test performance, while driving method robustness and investigation quality.  This position is responsible for effective communication with cross functional teams, organizing microbiology service requests, analyst training, development of skills and resource management. This position is responsible for execution of deliverables related to routine testing and project support. This position will also be responsible for laboratory inventory/supply management. This position will participate in new test method development for continuous improvement and capability expansion to support business needs.

Principal Responsibilities

•    Supervisory responsibilities and set work direction for a team of lab analysts.
•     Plan and manage laboratory workload, testing priorities, capacity, staffing, and resources to ensure timely execution of routine testing and project-related activities while maintaining quality and compliance requirements.
•    Develop and support validation strategies for microbiological test methods, including bioburden and bacterial endotoxin testing, as required to support laboratory and business needs. 
•    Ensure microbiology laboratory equipment and facilities are maintained in a qualified, calibrated, safe, and fit-for-purpose condition, and coordinate required maintenance, calibration, qualification, and corrective actions.
•    Lead and support the development, validation, verification, transfer, and implementation of microbiological test methods, including evaluation of method suitability and robustness, to support laboratory capability and business needs.
•    Monitor execution of routine product bioburden and/or bacterial endotoxin testing. Ensure testing is performed in accordance with approved procedures, applicable standards, and established laboratory requirements.
•    Establish clear communication of test status, issues, and expected timelines to stakeholders.
•    Review and approve test results generated by the microbiology lab according to QMS and good documentation practices
•    Lead and support laboratory nonconformance, deviation, OOS/OOT, and investigation activities, including root cause analysis, impact assessment, corrective actions, and effectiveness monitoring.
•    Prepare, review, and approve microbiology technical reports, investigation reports, impact assessments, and other laboratory documentation to ensure technical accuracy, completeness, and compliance with applicable QMS and GDP requirements.
•    Manage laboratory inventory and supplies to ensure adequate availability for routine and project activities, while identifying and implementing opportunities for process, efficiency, capacity, and cost improvements.
•    Identify and coordinate laboratory procurement and external service requirements, including equipment, consumables, calibration, maintenance, and laboratory services, in alignment with business needs and approved budgets.
•    Maintain laboratory capability and business continuity by identifying and mitigating risks related to staffing, equipment, materials, facilities, testing capacity, and operational disruptions.
•    Develop, coordinate, and maintain analyst training and competency programs for microbiological test methods, laboratory procedures, good documentation practices, and applicable quality requirements.
•    Execute testing to support sterilization cycle revalidations and product change assessments
•    Serve as the Microbiology Subject Matter Expert (SME) for cross-functional projects, product and process changes, validation activities, investigations, audits, and regulatory inspections, providing technical microbiology guidance and recommendations.
•    Ensure microbiology laboratory activities are conducted in accordance with applicable laboratory safety, biosafety, and chemical safety requirements, and promote a safe working environment for laboratory personnel.

Education / Experience Requirements

•    Bachelor’s Degree required in any scientific discipline
•    Minimum 5 years of microbiology laboratory, medical device, pharmaceutical related experience
•    Experience in laboratory management 
•     Laboratory testing experience in microbiological methods, including bioburden testing, environmental monitoring, or other applicable microbiological testing
•    Experience working within a Quality Management System

Specialized Skills / Other Requirements

•    Strong leadership skills with the ability to lead, develop, motivate, and manage laboratory personnel while effectively collaborating with cross-functional teams.
•    Thorough understanding of microbiology principles and laboratory practices applicable to medical device manufacturing, including bioburden testing, environmental monitoring, contamination control, and microbiological investigation.
•    Thorough understanding of laboratory requirements, aseptic techniques, contamination control practices, and microbiological laboratory operations.
•    Strong understanding and practical application of Quality Management System (QMS) requirements, Good Documentation Practices (GDP), and data integrity principles within microbiology laboratory operations.
•    Proficient in preparing, reviewing, and approving technical reports, investigation documentation, and microbiology-related technical documents with strong attention to accuracy, clarity, and compliance.
•    Structured and methodical problem-solving approach, with the ability to perform root cause analysis, assess laboratory risks and impacts, and develop effective corrective and preventive actions.
•    Ability to plan, organize, prioritize, delegate, and supervise individual and team activities effectively to meet laboratory, quality, and business requirements.
•    Strong verbal and written communication skills, with the ability to effectively coordinate activities, communicate laboratory status and technical information, and manage expectations across multiple internal and external stakeholders.
•     Ability to develop, review, and maintain microbiology procedures, work instructions, technical documents, and laboratory records in accordance with applicable QMS and document control requirements.
•    Strong interpersonal and collaborative skills, with the ability to work effectively both independently and as part of a cross-functional team while providing appropriate direction and support to laboratory personnel.
•    Foster a positive laboratory culture focused on employee development, collaboration, accountability, continuous improvement, and achievement of quality and business objectives.