Clinical Laboratory Manager

Ethos Holding Corp•Worcester, MA

About The Position

The Clinical Laboratory Manager oversees assigned laboratory departments—Instrumentation (LCMS), Confirmation, and Validations—in a high-complexity, high-throughput production environment. The role manages daily operations, supports supervisors and other employees, monitors technical and production performance, and identifies opportunities to improve processes, efficiency, and productivity while maintaining patient care and quality standards. The manager partners with laboratory and quality leaders on goals, projects, instrumentation, and new initiatives; maintains compliance with applicable regulations, policies, and SOPs; and supports accurate testing and reporting of patient specimens. The manager leads employee hiring, onboarding, training, competency assessment, performance review, coaching, and development. The role establishes effective communication across departments, facilitates department and laboratory-wide meetings, manages projects and resources, and maintains records for laboratory performance and equipment. Responsibilities also include oversight of laboratory instruments and equipment, particularly LC-MS/MS systems, the laboratory information system, supplies inventory, and participation in assay implementation, instrument evaluation, and method development. Work is performed in a laboratory environment with exposure to normal laboratory hazards, chemicals, and biohazard materials. The position requires wearing personal protective equipment when required and performing activities that include sitting, walking, reaching, bending, stooping, handling objects, talking, hearing, and seeing.

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 metric tracking 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 according to SOPs.
Ability and willingness to follow established protocols using acceptable forensic standards of analysis and sound judgment to find solutions or new applications within one's experience.
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 working in a high-throughput production laboratory.
Experience with CLIA, COLA, CAP, and/or NYS standards.
Relevant skills, knowledge, and experience to support the assigned departments, including Instrumentation (LCMS), Confirmation, and Validations.
Experience in high-throughput production and workflow in a clinical laboratory setting.
Experience with LC-MS/MS instrument operation, maintenance, and troubleshooting.
Experience with LC-MS/MS data analysis 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 issues related to LC-MS/MS data or patient results through direct communication with clients.
Leadership ability and capacity to manage groups of employees.
Ability to function in a team environment and promote collaboration; exercise independent judgment; and apply critical thinking and problem-solving skills with 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, delegate, and accomplish goals through others.
Effective oral and written communication skills.
Proficiency with Microsoft Office applications, especially Excel, and experience with laboratory software.
Ability and willingness to wear personal protective equipment (PPE) when required.

Nice To Haves

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

Responsibilities

Manage 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 department Supervisors and individual contributors.
Ensure departments meet established metrics, prioritize patient care, and provide laboratory services that meet industry standards and customer expectations.
Identify and implement opportunities to increase efficiency and productivity in instruments, processes, and workflows while minimizing downtime.
Collaborate with department leaders, the Quality Manager, the Director of Laboratory Operations, and the Lab Director to formulate and implement technical metrics and goals.
Ensure compliance with CLIA standards and regulations, Good Laboratory Practices (GLP), BSL-2 safety standards where applicable, SOPs, policies, budgets, schedules, and timelines.
Develop or expand SOPs and establish, improve, and implement procedures and processes by identifying and addressing issues and risks.
Ensure accurate testing of patient specimens according to established SOPs.
Act as the primary resource for escalated problem-solving across assigned departments; troubleshoot and analyze issues involving instruments, repairs, calibrations, quality controls, workflows, and patient data.
Use a teaching and coaching approach when troubleshooting with laboratory employees and support continuous learning and development.
Guide departmental planning for 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; and develop or implement employee training programs.
Use employee management practices to improve productivity and efficiency; delegate projects and tasks effectively and fairly.
Establish communication plans, facilitate communication within and across departments, and hold regular meetings for coaching, feedback, goals, metrics, initiatives, and employee feedback.
Work with Supervisors and team members to develop solutions that support business needs and quality objectives; collaborate with leaders to evaluate instrumentation, equipment, and consumables and keep projects on track without disrupting daily operations.
Participate in laboratory-wide meetings and present information to other departments.
Maintain records for performance indicators, certifications, repairs, service calls, and instrument and equipment maintenance.
Maintain laboratory instruments and equipment by reviewing performance specifications, ensuring quality standards, updating operating 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, new instrument evaluation, and LC-MS/MS method development for laboratory-developed tests.
Maintain laboratory supplies inventory, anticipate supply needs, and place or expedite orders.
Promote positive communication, collaboration, and teamwork; demonstrate Ethos Core Values; and maintain professional and technical knowledge through ongoing learning and development.
Perform other duties as assigned.