Clinical Laboratory Manager

Ethos Laboratories•Worcester, MA

About The Position

The Laboratory Manager oversees all aspects of assigned laboratory departments—Instrumentation (LCMS), Confirmation, and Validations—in a high-complexity, high-throughput production environment. The role manages daily operations, supports department Supervisors and other direct reports, monitors production and technical metrics, identifies process improvements, and partners with laboratory leaders on projects and initiatives. The Manager is accountable for effective communication and compliance with applicable regulations, policies, and SOPs. The position also oversees laboratory personnel, reporting, resources, training, performance assessment, equipment and supplies, and laboratory information system needs. It includes responsibility for LC-MS/MS instrument performance and maintenance, participation in assay and instrument initiatives, and ensuring accurate testing and appropriate records. The role works in a laboratory environment with normal laboratory hazards and chemicals, including biohazard materials.

Requirements

Experience supervising or managing individuals and teams in an accredited testing laboratory.
Demonstrated ability to coach, mentor, and train others.
Ability to evaluate training, competency, and job performance of Supervisors and individual contributors.
Experience establishing and monitoring employee metrics to support high performance.
Deep knowledge of high-complexity laboratory processes, instrumentation, and workflows.
Proficiency operating, maintaining, and troubleshooting a wide variety of laboratory instruments.
Experience creating and revising SOPs and working from SOPs.
Ability and willingness to follow established protocols using acceptable forensic standards of analysis, and to apply judgment in finding solutions or new applications within one’s experience.
Ability to listen, learn, and promote accountability and responsibility for processes.
Experience using laboratory information system (LIS) software.
Ability to maintain confidentiality and comply with HIPAA regulations.
Bachelor of Science in Toxicology, Chemistry, Biochemistry, Pharmacology, or a similar analytical science field with at least 5 years of relevant experience, or a Master of Science with at least 2 years of relevant experience.
Experience supervising or managing high-complexity toxicology laboratory departments.
Experience in a high-throughput production laboratory.
Experience with CLIA, COLA, CAP, and/or NYS standards.
Relevant skills, knowledge, and experience supporting Instrumentation (LCMS), Confirmation, and Validations departments.
Experience with high-throughput production and workflow in a clinical laboratory setting.
Experience operating, maintaining, and troubleshooting LC-MS/MS instruments.
Experience analyzing LC-MS/MS data for drug testing and biomarkers.
Experience reviewing, releasing, and certifying patient laboratory results.
Experience with LC-MS/MS method development, validation, verification, and troubleshooting.
Ability to resolve LC-MS/MS data or patient-result issues by communicating directly with clients.
Leadership ability and experience managing groups of employees.
Ability to work in a team environment and promote collaboration.
Ability to exercise independent judgment.
Critical thinking and problem-solving skills, with strong attention to detail.
Experience tracking statistics and identifying trends.
Excellent time-management, scheduling, documentation, and organizational skills.
Flexibility, innovation, and self-motivation.
Ability to motivate, coach, and mentor employees and delegate effectively to accomplish goals through others.
Effective oral and written communication skills.
Proficiency with Microsoft Office applications, especially Excel.
Experience with laboratory software.
Ability and willingness to wear personal protective equipment (PPE) when required.

Nice To Haves

A proven record of developing or optimizing laboratory processes.
Demonstrated exceptional troubleshooting abilities.
Urine toxicology experience.

Responsibilities

Manage the day-to-day operations of assigned laboratory departments: Instrumentation (LCMS), Confirmation, and Validations.
Provide leadership, guidance, problem-solving, follow-through, and support to direct reports, including Supervisors and individual contributors.
Ensure departments meet established metrics, prioritize patient care, and provide laboratory services that exceed industry standards and customer expectations.
Identify and implement opportunities to improve efficiency and productivity in instruments, processes, and workflows while minimizing downtime.
Collaborate with department leaders, the Quality Manager, Director of Laboratory Operations, and Lab Director to formulate and implement technical metrics and goals.
Ensure compliance with CLIA standards and regulations, Good Laboratory Practices, applicable BSL-2 safety standards, SOPs, and policies.
Manage adherence to budgets, schedules, and timelines, communicating proactively about needed adjustments.
Develop or expand SOPs and establish, improve, and implement laboratory procedures and processes; identify and address issues and risks.
Ensure accurate patient-specimen testing according to established SOPs.
Serve as the primary resource for escalated problem-solving across assigned departments and troubleshoot issues involving instruments, repairs, calibrations, quality controls, workflow, and patient data.
Coach and teach laboratory employees during troubleshooting to support continuous learning and development.
Guide departmental planning for future growth and new initiatives; prioritize project timelines and use project-management skills and tools.
Manage reporting, monitoring, resources, and laboratory personnel.
Participate in hiring and onboarding; conduct competency assessments and performance reviews; develop or implement training programs for new hires.
Use employee-management practices to improve productivity and efficiency, delegate work fairly, and hold monthly coaching and feedback meetings with direct reports.
Establish communication plans and facilitate communication within the laboratory and with internal and external departments.
Schedule and lead department meetings to share goals, metrics, and initiatives and to solicit feedback; participate in lab-wide meetings and present information to other departments.
Work with Supervisors and team members to find solutions that support business needs and quality objectives.
Collaborate with leaders to evaluate instrumentation, equipment, and consumables, and ensure cross-department communication and project progress without disrupting daily operations.
Maintain records of performance indicators, certifications, repairs, service calls, and equipment maintenance.
Maintain laboratory instruments and equipment by reviewing performance specifications, ensuring quality standards, updating procedures, and arranging service or repair, particularly for LC-MS/MS instruments.
Maintain the laboratory information system (LIS) by identifying information and workflow needs, recommending improvements, setting priorities, testing functionality, and updating training.
Participate in new assay implementation, instrument evaluation, and method development for LC-MS/MS instruments and laboratory-developed tests.
Maintain laboratory supply inventory, anticipate supply needs, and place or expedite orders.
Encourage positive communication, collaboration, and teamwork; demonstrate the Ethos Core Values and lead by example.
Maintain professional and technical knowledge through educational workshops, professional publications, networking, and leadership development.
Perform other duties as assigned.