Manager, Analytical Lab - Weekend PM Shift

About the role

At Exact Sciences, we’re helping change how the world prevents, detects, and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.

Responsibilities

• Directs the daily workflow of the clinical laboratory departments; including, but not limited to, ensuring processing systems for patient and study samples are functioning properly, monitoring quality control testing results, and monitoring quality assurance performance metrics.
• Manages designated laboratory and cross-functional projects such as process improvements, quality improvements, clinical validation studies, and the development and launch of new products.
• Collaborates with Exact Sciences’ human resources department and participates in the employee hiring and management process by interviewing candidates, hiring, and employee counseling.
• Affirms scheduling needs of the departments to ensure adequate coverage to meet service needs.
• Identifies and understands regulatory requirements to ensure that the laboratory complies with all applicable state and federal laws and regulations pertinent to the management of the laboratory; including applicable CLIA, CAP, and other requirements and regulations such as California and New York (CLEP) laboratory programs.
• Manages the inspection preparation activities in the clinical laboratory, such as maintaining consistent, ongoing readiness for inspections and representing the clinical laboratory during inspections.
• Provides or delegates responsibility of supervision of the clinical laboratories and is accessible to the laboratory personnel to provide on-site, telephone, or electronic consultation.
• Maintains a process for staffing, recruiting, training, evaluating competency, and ongoing employee development.
• Works strategically with department supervisors and managers to ensure testing is completed within turnaround time.
• Promotes partnerships with senior management in establishing strategic priorities and annual quality indicators.
• Collaborates with the laboratory leadership to assist in developing and providing continuing education credits for the laboratory staff.
• Ensures staff are properly trained and competent in all aspects of their job duties and departmental procedures.
• Reviews, writes, and updates standard operating procedures (SOPs).
• Reviews and writes nonconformance and deviation approval requests, and other documents, as appropriate.
• Possesses effective management skills to supervise department staff and maintain departmental budgets.
• Provides oversight to ensure prompt, accurate, and timely processing, and delivery of all patient specimens.
• Evaluates equipment and supply needs of the laboratory.
• Partners with the laboratory leadership to maintain operations within the budget.
• Assures timely and appropriate ordering of supplies and equipment.
• Maintains supply usage and variances.
• Reviews test volumes with laboratory leadership to develop and implement timely changes to manage workload.
• Verifies test procedures performed, and with assistance, establishes the laboratory’s test performance characteristics, including precision and accuracy of each test and test system.
• Safeguards the quality management program by following parameters for acceptable performance for the pre-analytical, analytical, and post-analytical testing processes.
• Solves high complexity technical problems, with the aid of the technical staff and ensures that remedial action is taken whenever a test deviates from the laboratory’s performance standards.
• Ensures that all patient results are not reported until corrective actions have been taken and the systems are functioning properly.
• Identifies training needs and ensures all training is performed, as required.
• Assists with the training of new laboratory personnel and training of new procedures with existing personnel, as needed.
• Evaluates competency of all laboratory personnel.
• Supervises staff; including, but not limited to, organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.
• Communicates goals clearly to employees to ensure understanding and success in achieving them.
• Motivates and inspire employees to do their best work through coaching and mentoring.
• Maintains morale and supports employee engagement initiatives.

Requirements

• Bachelor’s Degree in Chemical, Biological, or Clinical Laboratory/Medical Technology Science or field related to the essential duties.
• 6+ years of experience working in a clinical laboratory setting.
• 3+ years of experience leading and managing teams.
• Demonstrated ability working in a high-volume laboratory operations environment.
• Demonstrated ability working with quality management programs.
• Strong working knowledge in the areas of laboratory technology, management principles, laboratory information system (LIS) management, and workflow needs and capabilities.
• Strong knowledge of all laws and regulations that are required by CLIA, CAP, OSHA, and other related legislative and/or state health departments and organizations.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Qualifications

• Advanced Degree.
• 2+ years of experience with LIS requirements and workflow needs.
• 2+ years of experience working with quality management; including strong knowledge of all laws and regulations that are required by CLIA, CAP, OSHA, New York, and other related legislative and/or state health departments and organizations.
• Experience with one or more standard molecular biology techniques such as nucleic acid isolation, RNA/DNA quantification, PCR and RT-PCR, and DNA sequencing.
• Experience with high-throughput robotic instruments.
• Familiarity with FDA regulations of Laboratory Developed Tests (LDT).
• Familiarity with ISO standards.

Skills

• Excellent customer service skills.
• Ability to work well with all members throughout the organization.
• Excellent verbal and written communication skills.
• Excellent presentation skills, including public speaking.
• Excellent analytic skills.
• Able to organize work and meet deadlines.
• Excellent time management skills.
• Able to effectively evaluate situations and work with teams to develop appropriate resolutions.
• Able to quickly implement and adapt to change.
• Able to apply project management skills to leadership of operational expansion and process improvements.
• Able to quickly and calmly adapt and respond to changes in priorities, timelines, and deliverables.
• Able to communicate clearly and effectively in writing and verbally to technical and non-technical audiences.
• Able to integrate and apply feedback in a professional manner.
• Able to prioritize and drive to results while maintaining a consistently high-quality standard.
• Able to work as part of a team.
• Upholds company mission and values through accountability, innovation, integrity, quality, and teamwork.

Benefits

The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible. Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.