Clinical Laboratory Manager

Description

JOB OVERVIEW

The Laboratory Manager is responsible for managing all aspects of their respective laboratory departments in a high-complexity, high-throughput production environment, which includes Instrumentation (LCMS), Confirmation, and Validations. This role will manage day-to-day operations, identify opportunities for process improvement and operational efficiencies, reinforce standards of practice, provide leadership support to department Supervisors, monitor production and technical metrics/goals, and partner with other leaders on new projects or initiatives. In addition, this person will establish effective communication plans, hold and participate in various meetings, and be accountable for compliance with regulations, policies, and SOPs.

ESSENTIAL FUNCTIONS

• Manage the day-to-day operations of all assigned laboratory departments
• Provide consistent leadership, guidance, problem-solving, follow-through, and support to direct reports, which may include department Supervisors and/or individual contributors
• Ensure all departments meet established metrics, prioritize patient care, and provide laboratory services that exceed industry standards and customer expectations
• Identify opportunities and take steps to increase efficiency and productivity with instruments, processes, and workflows, minimizing downtime while maintaining optimum conditions
• Collaborate with department leaders, Quality Manager, Director of Laboratory Operations, and Lab Director to formulate and implement technical metrics/goals
• Ensure adherence to CLIA standards and regulations
• Ensure adherence to Good Laboratory Practices (GLP) and BSL-2 safety standards (where applicable)
• Ensure adherence to budgets, schedules, and timelines; planning and communicating proactively when adjustments need to be made
• Ensure adherence to Standard Operating Procedures (SOPs) and Policies; develop/expand current SOPs as needed
• Establish, improve, and implement procedures and processes by identifying and addressing issues and risks in assigned laboratory departments, including Instrumentation (LCMS), Confirmation, and Validations 
• Ensure accurate testing of patient specimens following established SOPs
• Serve as the primary resource for escalated problem-solving across all assigned laboratory departments, including Instrumentation (LCMS), Confirmation, and Validations
• Utilize a teaching/coaching approach when troubleshooting issues alongside lab employees for continuous learning and development opportunities
• Identify, troubleshoot, and analyze issues or trends related to instrument operation, instrument repair, calibrations, quality controls, workflow, patient data, etc.
• Guide departmental planning for future growth or new initiatives 
• Prioritize timelines for projects and new initiatives, utilizing project management skills/tools
• Manage reporting, monitoring, resources, and laboratory personnel
• Participate in the hiring and onboarding process across all assigned laboratory departments, including Instrumentation (LCMS), Confirmation, and Validations
• Conduct competency assessments and/or performance reviews for direct reports
• Develop and/or implement an effective employee training program for new hires
• Utilize proven employee management solutions to improve productivity and efficiency
• Delegate projects, tasks, and initiatives effectively and fairly
• Establish effective communication plans with each department
• Facilitate effective communication across internal departments and to external departments
• Hold monthly meetings for ongoing coaching and feedback for direct reports
• Work closely with Supervisors and/or team members to provide effective solutions to support business needs and quality objectives
• Collaborate with other leaders to evaluate current instrumentation, equipment, and consumables regularly 
• Collaborate with other leaders to ensure proper communication is established between departments and projects are on track and will not hinder daily operations
• Schedule and lead meetings within each department to share goals, performance metrics, upcoming initiatives/projects, solicit feedback, etc.
• Participate in lab-wide meetings to present information to other departments
• Ensure appropriate records are maintained for performance indicators, certifications, repairs, service calls, and maintenance for lab instruments and equipment 
• Maintain laboratory instruments/equipment by reviewing performance specifications, ensuring quality standards, editing operating procedures as needed, arranging service/repair, etc., specifically LC-MS/MS instruments
• Maintain laboratory information system (LIS) by identifying information or workflow needs/issues, recommending improvements, establishing priorities, testing functionality, updating training, etc.
• Participate in new assay implementation, new instrument evaluation, and/or method development for LC-MS/MS instruments with lab-developed tests
• Maintain laboratory supplies inventory, anticipate needed supplies, place and expedite orders for supplies
• Exemplify and encourage positive communication and interactions within the lab to inspire collaboration and teamwork
• Lead by example and demonstrate the Ethos Core Values consistently 
• Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, identifying ongoing leadership development, etc.
• Other duties as assigned

Requirements

PROFESSIONAL REQUIREMENTS

• Experience in supervising/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 with establishing and monitoring employee metric tracking to ensure high performance
• Deep knowledge of high-complexity laboratory processes, instrumentation, and workflows
• Proficient in operating, maintaining, and troubleshooting a wide variety of laboratory instruments
• Experience creating, revising, and operating from SOPs
• Able and willing to follow established protocols employing acceptable forensic standards of analysis and the use of judgment in searching for solutions or new applications within one’s own experience
• Ability to listen, learn, and promote accountability and responsibility related to all processes
• Experience using laboratory information system (LIS) software
• Ability to maintain the highest level of confidentiality and adherence to HIPAA regulations

EDUCATION AND EXPERIENCE REQUIREMENTS

• Bachelor of Science in Toxicology, Chemistry, Biochemistry, Pharmacology, or similar analytical science field with minimum of 5 years of relevant experience; OR Master of Science with minimum of 2 years of relevant experience
• Requires experience supervising or managing high-complexity toxicology laboratory departments
• Requires experience in a high-throughput production laboratory
• Requires experience with CLIA, COLA, CAP, and/or NYS standards 
• Must have relevant skills, knowledge, and experience to support the departments reporting to the Laboratory Manager, including Instrumentation (LCMS), Confirmation, and Validations
• Preference for candidates with a proven record of developing or optimizing lab processes
• Preference for candidates with demonstrated exceptional troubleshooting abilities
• Preference for candidates with urine toxicology experience

KNOWLEDGE, SKILLS AND ABILITIES

• Must have specific experience for key tasks of all assigned laboratory departments, such as: 
• High-throughput production and workflow in a clinical laboratory setting
• LC-MS/MS instrument operation, maintenance, and troubleshooting
• LC-MS/MS data analysis for drug testing, biomarkers
• Review, release, and certifying of patient lab results
• LC-MS/MS method development, validation, verification, and troubleshooting
• Resolving issues related to LC-MS/MS data or patient lab results by communicating directly with clients
• Must consistently demonstrate leadership qualities and be able to manage groups of employees
• Ability to function in a team environment and promote collaboration
• Ability to exercise independent judgment
• Critical thinking and problem solving, with a high level of attention to detail
• Must have experience tracking statistics and identifying trends
• Excellent time management, scheduling, documentation, and organizational skills
• Must be flexible, innovative, and self-motivated
• Must be able to motivate, coach, and mentor employees for highest level of performance
• Must be able to delegate and accomplish goals through others
• Ability to communicate effectively, orally and in writing
• Proficient with Microsoft Office applications, especially Excel
• Must be experienced with laboratory software

PHYSICAL REQUIREMENTS

• Must be able and willing to wear personal protective equipment (PPE) when required 
• Work is performed in a laboratory environment and exposes the incumbent to normal laboratory hazards and chemicals, including biohazard materials
• Work in varying degrees of temperature (heated or air conditioned)
• Position requires sitting, walking, reaching, bending, stooping, and handling objects with hands and/or fingers, talking and/or hearing, and seeing

DIRECT REPORTS

• Department Supervisors and/or Individual Contributors for assigned laboratory departments of Instrumentation (LCMS), Confirmation, and Validations
• LCMS Supervisor and/or LCMS Specialists
• Confirmation Supervisor and/or Certifying Scientists
• Validations Supervisor and/or Analytical Development Scientists, Bench Chemists