Manager, Clinical Laboratory

Abbott • Phoenix, AZ

2d • Onsite

About The Position

The Manager, Clinical Laboratory oversees daily clinical laboratory operations at Abbott’s Phoenix, Arizona location, supporting Molecular Diagnostics in the Cancer Diagnostics division. The role develops procedures that support safety, quality, and accurate results; supervises and develops laboratory staff; provides technical expertise; and serves as a liaison to internal and external groups. The manager oversees the laboratory’s quality management program and ensures compliance with applicable CLIA, CAP, OSHA, state, and federal requirements.

The position collaborates across departments to ensure patient and clinical validation study samples are processed accurately and on time, and is accountable for laboratory deliverables on designated product and process development projects. It also coordinates service coverage and staffing, and may perform high-complexity testing on patient specimens, interpret and report results, and troubleshoot technical and non-technical issues.

The role is responsible for laboratory workflow, inspection readiness, staffing and competency, procedures and documentation, quality performance, equipment and supplies, budgets, and timely delivery of patient results. The manager works with laboratory leadership and senior management on operational and quality priorities, process improvements, clinical validation studies, and development and launch of new products. The position requires the ability to work the designated schedule, including nights and/or weekends.

Requirements

• Bachelor’s degree in Chemical, Physical, Biological, Clinical Laboratory/Medical Technology Science, or a field related to the essential duties.
• At least 6 years of experience working in a clinical laboratory setting.
• At least 3 years of experience leading and managing teams.
• Experience troubleshooting NGS issues in a molecular laboratory.
• Demonstrated ability to work in a high-volume laboratory operations environment.
• Demonstrated ability to work with quality management programs.
• Strong working knowledge of laboratory technology, management principles, laboratory information system (LIS) management, and workflow needs and capabilities.
• Strong knowledge of applicable laws and regulations, including CLIA, CAP, OSHA, and related legislative and state health department requirements.
• Proficiency in Microsoft Office.
• Authorization to work in the United States without sponsorship.
• Ability to perform the essential duties with or without accommodation.
• Excellent customer service, verbal and written communication, presentation, analytical, organization, and time-management skills.
• Ability to evaluate situations, develop resolutions with teams, adapt to change, manage projects, prioritize work, meet deadlines, and maintain quality.
• Ability to work effectively as part of a team and communicate with technical and non-technical audiences.
• Ability to work the designated schedule, including nights and/or weekends.
• Ability to move 40 pounds for approximately 25% of a typical working day.
• Ability to work seated for approximately 50% and standing for approximately 50% of a typical working day.
• Ability to use a mobile device, tablet, or computer and/or type for approximately 90% of a typical working day.
• Ability to grasp with both hands, pinch with thumb and forefinger, turn with hand or arm, reach above shoulder height, stand, bend, and transfer materials.
• Ability to maintain regular and reliable attendance and integrate feedback professionally.

Nice To Haves

• Advanced degree.
• At least 2 years of experience with LIS requirements and workflow needs.
• At least 2 years of experience working with quality management and strong knowledge of requirements including CLIA, CAP, OSHA, New York, and other applicable state health departments and organizations.
• Experience with molecular biology techniques such as nucleic acid isolation, RNA/DNA quantification, PCR, RT-PCR, and DNA sequencing.
• Experience with high-throughput robotic instruments.
• Familiarity with FDA regulations for Laboratory Developed Tests (LDT).
• Familiarity with ISO standards.

Responsibilities

• Direct daily clinical laboratory workflow, including patient and study sample processing systems, quality control results, and quality assurance metrics.
• Manage laboratory and cross-functional projects, including process and quality improvements, clinical validation studies, and new product development and launch.
• Participate in hiring and employee management, including interviewing candidates and counseling employees.
• Assess scheduling and staffing needs to ensure adequate service coverage and timely testing.
• Ensure laboratory compliance with applicable state and federal requirements, including CLIA, CAP, OSHA, and relevant state laboratory programs.
• Maintain inspection readiness and represent the clinical laboratory during inspections.
• Provide or delegate laboratory supervision and make consultation available to personnel on-site, by telephone, or electronically.
• Manage staffing, recruiting, training, competency evaluation, and ongoing employee development.
• Work with supervisors and managers to ensure testing is completed within turnaround times.
• Partner with senior management to establish strategic priorities and annual quality indicators.
• Assist laboratory leadership in developing and providing continuing education credits for staff.
• Ensure staff are trained and competent in their duties and departmental procedures.
• Review, write, and update standard operating procedures; prepare nonconformance, deviation, and other documents as appropriate.
• Supervise staff, organize and prioritize work, conduct performance reviews, develop employees, and manage work performance.
• Maintain departmental budgets and work with laboratory leadership to keep operations within budget.
• Oversee prompt, accurate, and timely processing and delivery of patient specimens.
• Evaluate laboratory equipment and supply needs; ensure timely ordering and monitor supply use and variances.
• Review test volumes with laboratory leadership and implement timely workload adjustments.
• Verify test procedures and, with assistance, establish test performance characteristics, including precision and accuracy.
• Maintain the quality management program across pre-analytical, analytical, and post-analytical testing processes.
• Resolve high-complexity technical problems and ensure remedial action when testing deviates from performance standards.
• Ensure patient results are not reported until corrective actions are complete and systems are functioning properly.
• Communicate goals clearly, coach and mentor employees, support engagement and morale, and model inclusive behaviors.
• Uphold company mission and values and comply with Quality Management System policies and procedures.

Benefits

• Career development opportunities with an international company.
• Potential eligibility for free medical coverage through the Health Investment Plan PPO in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, offering an affordable and convenient path to a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager