Pre-Analytical Laboratory Manager

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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.

Position Overview

The Manager, Pre-Analytical Laboratory will oversee the operations of PreventionGenetics’ Pre-Analytical department, including Accessioning the Extraction Lab, and Genetic Testing Coordinators to ensure scalability and consistent quality of pre-analytical laboratory operations. This individual will ensure all pre-analytical systems are functioning properly to consistently achieve turnaround time targets. The Manager, Pre-Analytical Laboratory will also conduct all quality-related activities as specified in the Quality Management System and be sure the department meets regulatory compliance and service quality. This individual will lead the Pre-Analytical department through projects and improvement activities that contribute directly to PreventionGenetics key results, ensuring budgets, project schedules and business requirements are met.

The Manager, Pre-Analytical Laboratory will serve as a liaison between Pre-Analytics and various functional groups; including, but not limited to, customer service, the Analytical laboratory, Post-Analytical Department, process and service engineering, information technology, human resources, quality, supply chain management and workplace services to report and address immediate issues or concerns. The Manager will also participate in cross-functional teams that improve the infrastructure, workflow and processes throughout our Clinical Laboratory to accommodate rapidly growing assay volumes, an expanding test menu, introduction of new technologies and business models, expansion to multiple laboratory sites, and continuous changes in the external regulatory landscape. This individual will consult with Quality and provide guidance to the Accessioning and Extraction Lab teams to address non-conformances, complaints and CAPAs within the Pre-Analytical department at PreventionGenetics.

Essential Duties

Include, but are not limited to, the following:

• Manage the operations of the Pre-Analytical Department including but not limited to the following: anticipating, planning for, and acquiring the required staffing, equipment, space, and workflow improvements for pre-analytical laboratory operations; monitoring quality assurance performance metrics; planning, validation and implementation of new process procedures or equipment; leading and supervision of personnel; managing resources, project timelines and deliverables.
• Collaborate with the Accessioning Associate Supervisor, the Extraction Lab Associate Supervisor and the GTC Supervisor on tasks including but not limited to recruitment, goal setting, professional development, mentoring, training and competency assessment, performance assessments and compliance.
• Lead and maintain the engagement of staff and project team members, practicing above-the-line communication to create a culture of accountability, and encouraging activities to foster team building.
• Collaborate with other functional groups to capture and analyze actionable data, to identify and implement new processes and practices, based on evidence, for continuous improvements and to achieve performance targets.
• Ensure consistent compliance with all applicable federal, state, local and international regulatory requirements and with all company policies and procedures.
• Complies with safety protocols.
• Under the guidance of Quality, provide guidance to the Pre-Analytical department and support personnel to ensure timely and effective investigation, documentation, corrective action, and preventive action associated with nonconformance, complaints and CAPAs occurring within the Clinical Laboratory.
• Maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and/or employee safety, and immediately communicating these to the appropriate management representatives as necessary to ensure prompt resolution.
• Lead or participate in Pre-Analytical process improvement activities with support from Engineering, Quality, and other functional teams. Ensure that implementation of improvements run smoothly and that gains are sustained.
• Contribute to inspection preparation efforts with Quality and various support teams. The activities include, but are not limited to, staff training, review of checklists and formulate responses, internal audits of documents and records, and mock inspections.  Support discussions with the inspectors on department operational topics and ensure that any deficiencies or findings are addressed efficiently within the specified timeline.
• Participate in developing, modifying, and executing company policies that affect immediate pre-analytical laboratory operations and may also have company-wide effect.
• Strong desire to work in a dynamic interdisciplinary team environment.
• Ability to work on problems in which analysis of situations or data requires an evaluation of various factors, including the impact to service quality and test results.
• Ability to effect improvements in operational performance and quality by identifying and leading beneficial changes in operational processes, behavior, physical location and layout of lab space, team structure and other efforts as assigned.
• Ability to influence effectively to create synergy, prioritize projects, set goals and actions plans, implement plans and measure impact.
• Ability to communicate effectively at all organizational levels and in situations requiring instruction, conflict resolution, consulting and advising, as well as effective written communication.
• Ability to plan, organize, prioritize, manage multiple changing priorities, work effectively in a team or independently and drive to results with a high emphasis on quality.
• Consistent demonstration of exceptional leadership qualities, including but not limited to the ability to attract and retain the best team, foster a culture of high performance, lead with integrity, humility, accountability, and courage, and set a clear vision to energize teams towards the future.  
• Effectively manage, support, and guide your team, including, but not limited to delegating tasks and responsibilities, assess employee performance and provide helpful feedback and training opportunities.
• Ability to integrate and apply feedback in a professional manner.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to lift up to 5 pounds for approximately 5% of a typical working day.
• Ability to work seated for approximately 50% of a typical working day. Ability to work standing for approximately 50% of a typical working day.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high speed centrifugation.
• Use of computer, and or phone for long periods of time may be necessary, and considerable periods of time may be spent concentrating, reading, or analyzing data, or applying scientific rules.
• May perform repetitious actions using lab tools.
• Some time spent using near vision to view samples at close range.
• Use of various chemicals may be used to perform duties.
• Ability to travel <5% of working time away from work location, may include overnight/weekend travel.
• Ability to flex hours worked in order to effectively manage all personnel within the department including second and third shift workers.

Minimum Qualifications

• Doctoral degree in clinical laboratory science, chemical, or biological science with 2 year training and experience in the respective specialty; OR Master's degree in medical technology, clinical laboratory science, or chemical, or biological science and 4 years training and experience in high-complexity testing in the respective specialty; OR Bachelor's degree in medical technology, clinical laboratory science, or chemical, or biological science and 6 years training and experience in high-complexity testing in the respective specialty.
• 8+ years of relevant experience which may include:
  • 8+ years in a regulated environment such as manufacturing, clinical laboratory pre-analytical sample processing, biobanking, biomedical material processing, or equivalent.
  • 5+ years of experiences in leading process or quality improvement projects, allocating resources and prioritizing key deliverables to optimize delivery timelines while meeting all critical requirements.
  • 5+ years of management experience with a proven track record of implementing changes, scaling operations for growth, staff development, and building successful teams.
• General knowledge and understanding of CAP, GLP, GDP, CLIA, New York Department of Health (NYDOH) and HIPAA.
• Knowledge of Microsoft Office Suite tools, quality, and document control systems.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time.

Preferred Qualifications

• ASCP certification.
• Knowledge of local, state, federal and international laboratory regulations, international standards for quality management systems.
• Knowledge of or experience in cost benefit analysis.
• Ability to apply performance improvement tools and methodologies such as Lean, JIT, Six Sigma and Flow Manufacturing techniques, FMEA, etc.
• Project management experience.

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Salary Range:

$105,000-$150,000

 

The annual base salary shown is for this position located in US - CA - Redwood City on a full-time basis and may differ by hiring location. 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.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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