Director Of Laboratory Operations

JOB OVERVIEW

The Director of Laboratory Operations is responsible for leading and overseeing operations and technical aspects in all lab departments in a high-complexity, high-throughput production environment, including Accessioning, Initial Testing, Confirmation, Instrumentation, Microbiology, and Validations. This includes developing strategies for process improvement and operational efficiencies, establishing and prioritizing project timelines, formulating technical goals, establishing and reinforcing standards of practice, supporting those who manage daily operations of all departments, and partnering with other leaders to ensure proper alignment on initiatives. In addition, this person will establish effective communication plans, hold and participate in various leadership and department meetings, be accountable for compliance with regulations, and develop new processes for instrumentation and testing methods.

ESSENTIAL FUNCTIONS

• Oversee the operations of all laboratory departments to meet established metrics, prioritize patient care, and provide laboratory services that exceed industry standards and customer expectations
• Provide consistent leadership, guidance, problem-solving, follow-through, and support to direct reports
• Serve as an expert-level resource for questions related to LC-MS/MS, EIA, ELISA, MALDI-TOF, and PCR
• Delegate projects, tasks, and initiatives effectively and fairly
• Evaluate and improve existing training programs across all departments
• Ensure adherence to CAP, CLIA, and NYS standards and regulations
• Ensure adherence to Good Laboratory Practices (GLP) and BSL-2 safety standards (where applicable)
• Ensure adherence to Ethos Standard Operating Procedures (SOPs) and Policies
• Develop strategies for process improvement, operational efficiencies, and department growth
• Establish and prioritize timelines for projects and new initiatives, utilizing project management skills/tools
• Hold monthly meetings for ongoing coaching and feedback for direct reports
• Collaborate with department leaders, Quality Manager, and Lab Director to formulate technical goals
• Partner with other cross-functional leaders and the Executive team to ensure proper alignment on company initiatives, departmental budgets, and to respond efficiently to business requirements and needs
• Establish effective communication plans with each department, with the lab as a whole, and cross-functionally with other teams
• Hold and participate in various leadership and lab meetings to share goals, performance metrics, upcoming initiatives/projects, solicit feedback, etc.
• Utilize a teaching/coaching approach when troubleshooting issues alongside lab employees for continuous learning and development opportunities
• Develop, edit, and implement policies, procedures, and controlled documents
• Take steps to increase efficiency and productivity with instrument processes and workflows, minimizing downtime while maintaining optimum conditions
• Develop and implement new processes for instrumentation, testing methods, and Laboratory Information System (LIS) functionality
• Ensure appropriate records are maintained for performance indicators, certifications, repairs, service calls, and maintenance for lab instruments and equipment
• Establish, monitor, and report department metrics for specimen integrity, turnaround time, accuracy, throughput, expenses, etc.
• Identify, troubleshoot, and analyze issues or trends related to instrument operation, instrument repair, calibrations, quality controls, workflow, patient data, etc.
• Interview, hire, onboard, and train new employees; complete competency assessments on schedule
• Exemplify and encourage positive interactions within the lab to inspire collaboration and teamwork
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies
• Other duties as assigned

PROFESSIONAL REQUIREMENTS

• Experience managing/supervising individuals and teams
• Experience creating, revising, and operating from SOPs
• Experience monitoring and improving operational efficiencies
• Deep knowledge of LC-MS/MS instrument operation, maintenance, troubleshooting, and methods
• Deep knowledge of toxicology, biochemistry, immunoassay, chemistry, and PCR processes, instrumentation, and workflows
• Proficient in operating, maintaining, and troubleshooting a wide variety of Laboratory instruments
• Experience with method development and method validation, specifically with LC-MS/MS and PCR
• Ability to maintain the highest level of confidentiality and adherence to HIPAA regulations
• Ability to model and foster in others time management, conscientiousness, dedication, and accountability
• Ability to listen, learn, and promote accountability and responsibility related to all processes
• 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
• Must be able and willing to wear personal protective equipment (PPE) when required
• Proficient with Microsoft Office applications

EDUCATION AND EXPERIENCE REQUIREMENTS

• Bachelor of Science in Chemistry, Toxicology, Pharmacology, Life Science, Biology, Physics, Engineering, or similar analytical science field with minimum of 7 years of relevant experience; OR Master of Science or Ph.D. with minimum of 5 years of relevant experience
• Must have experience managing or directing a high-complexity laboratory
• Must have experience in a high-throughput production laboratory
• Must have experience with CLIA, COLA, CAP, and/or NYS standards
• Must have experience with LC-MS/MS and urine toxicology
• Preference for candidates with a proven record of developing or optimizing lab processes
• Preference for candidates with demonstrated exceptional troubleshooting abilities

KNOWLEDGE, SKILLS AND ABILITIES

• Critical thinking and problem solving, with a high level of attention to detail
• Must consistently demonstrate leadership qualities and lead by example
• Ability to communicate effectively, orally and in writing
• 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
• Must be experienced with laboratory software

PHYSICAL REQUIREMENTS

• 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

• Production Manager
• LCMS Engineer
• Confirmation Supervisor
• PCR Supervisor
• Validations Supervisor and/or Technical Supervisor
• Core Lab Supervisor (Massachusetts location)

This description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.