Manager, Clinical Laboratory

Abbott • Phoenix, AZ

4d • $99,300 - $198,700 • 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 to ensure safety, quality, and accurate results; supervises and develops laboratory staff; provides technical expertise; and serves as a liaison to internal and external entities. The manager oversees the laboratory quality management program and ensures compliance with applicable CLIA, CAP, OSHA, New York, and other state and federal requirements.

The position collaborates with departments and cross-functional teams 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 coordinates service coverage, staffing, and issue resolution for commercial patient samples. The manager may also perform high-complexity testing, interpret and report patient results, and troubleshoot technical and non-technical problems.

The role includes directing workflow, managing projects and budgets, maintaining inspection readiness, overseeing hiring and staff development, and ensuring test quality and turnaround times. The position is based at 445 North 5th St, Phoenix, Arizona. The listed work shift is standard; travel is not required.

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 next-generation sequencing (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 laws and regulations required by CLIA, CAP, OSHA, and related legislative or state health departments and organizations.
• 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, organizational, and time-management skills.
• Ability to evaluate situations, develop resolutions with teams, adapt to change, manage projects, prioritize work, meet deadlines, and maintain quality standards.
• Ability to communicate effectively with technical and non-technical audiences, work collaboratively, and professionally integrate feedback.
• Ability to work the designated schedule and 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.

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, including knowledge of CLIA, CAP, OSHA, New York, and other related regulatory requirements.
• 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, ensuring patient and study sample processing systems function properly and monitoring 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, hiring, and employee counseling.
• Assess scheduling needs and ensure adequate staffing coverage for service needs.
• Identify applicable regulatory requirements and ensure laboratory compliance with state and federal laws and regulations, including CLIA and CAP requirements.
• Manage inspection preparation, maintain ongoing inspection readiness, and represent the clinical laboratory during inspections.
• Supervise the clinical laboratories and provide or delegate accessible consultation to laboratory personnel.
• Maintain processes for staffing, recruiting, training, competency evaluation, and employee development.
• Coordinate with supervisors and managers to ensure testing is completed within turnaround time.
• Partner with senior management to establish strategic priorities and annual quality indicators.
• Help develop and provide continuing education credits for laboratory staff.
• Ensure staff are trained and competent in their duties and departmental procedures.
• Review, write, and update standard operating procedures; review and write nonconformance and deviation approval requests 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 usage and variances with supervisors.
• Review test volumes with laboratory leadership and implement timely workload management changes.
• 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 processes.
• Resolve high-complexity technical problems with technical staff and ensure remedial action when tests deviate from performance standards.
• Ensure patient results are withheld until corrective actions are complete and systems are functioning properly.
• Identify training needs, provide or assist with training, and evaluate the competency of laboratory personnel.
• Communicate goals, coach and mentor employees, support engagement, and maintain morale.
• Provide excellent customer service and collaborate effectively across the organization.
• Support the company’s Quality Management System and uphold its mission and values, including accountability, innovation, integrity, quality, teamwork, and inclusion.
• Maintain regular and reliable attendance and work the designated schedule, which may include nights and/or weekends.

Benefits

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

What This Job Offers

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