Director, Clinical Laboratory - Specimen Processing
Summary of Major Responsibilities
This role, known internally as the Director, Specimen Processing, will lead teams in specimen receiving, accessioning and processing. This role will drive process improvements, lean philosophy, validation and transfer of new processes and systems into the specimen processing laboratory. The position will lead the Specimen Processing team in developing and documenting new procedures for each specimen type. The position will be responsible for equipping, staffing and establishing systems for receiving and processing laboratory specimens according to established specimen acceptability and preparation criteria. This role will serve as the primary leader for all investigations and non-conformances associated with specimen processing as well as oversee cross-functional projects implementing best practices to ensure the area meets business needs. Additionally, develop flexible and consistent processes to support clear communication to all levels within the laboratory. Lead and inspire the Specimen Processing team by setting direction and creating a work environment that encourages goal realization and employee growth.
Essential Duties and Responsibilities
- Collaborate with clinical laboratory teams in developing, transferring, scaling and validating specimen pre-analytic processes, including specimen acceptability, accessioning, specimen preparation in accordance with CLIA, CAP and quality guidelines.
- Develops flexible and consistent processes to support clear communication to all levels within the laboratory.
- Provide leadership to the team by promoting communication and collaboration, proactively supporting employee development initiatives and promoting cross-functional collaboration and teamwork.
- Provides visibility and supporting information to assist leadership in prioritization of projects based on changing functional needs, resource capacity constraints, risk exposure, and ensuring clarity in project interdependencies.
- Oversee people leaders as well as individual contributors defining clear roles, responsibilities and expectations for department staff.
- Oversee the department schedule working closely with department managers and supervisors.
- Coordinate, lead, mentor, and support process improvement projects within functional roles to drive cost savings, efficiencies and productivity. Quantify savings through partnering with financial analysts.
- Drive teams through root cause analysis/nonconforming event analysis associated with specimen processing using quality system tools (5 Whys, FMEA, fishbone diagrams etc.).
- Develop and oversee training for all employees within the specimen processing department in collaboration with training teams.
- Mentors next level supervisors, managers and leaders within the department to continue to grow talent within the laboratory.
- Supervise staff including but not limited to organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.
- Excellent leadership skills to be a primary leader for a diverse team with specialized expertise.
- Takes initiative to improve systems, processes, procedures to drive quality into daily production.
- Executes and leads the team with a sense of urgency.
- Ability to effectively communicate to all levels within the company and thrive in a fast-paced, ever changing environment.
- Ability to comprehend procedures, processes and experimental designs to provide guidance and support to teams.
- Strong documentation skills and attention-to-detail necessary in a CLIA/CAP regulated environment.
- Excellent analytical skills.
- Ability to course correct when issues arise with strong tactical and clear execution plans.
- Must possess strong coaching/counselling skills to support performance management.
- Proven ability to work effectively cross-functionally in project team situations, influence and collaborate with stakeholders as well as work independently leading teams forward with a clear vision.
- Ability to make decisions based on data and lead teams through ambiguous situations.
- Demonstrated success with oral and written communications/presentations, influence and persuasion, results orientation, facilitation, and teamwork skills.
- 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.
- Regular and reliable attendance.
- Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
- Ability to use and wear safety protective gear/equipment (e.g. safety glasses, lab coat, gloves, etc.) and follow safety guidelines while in the lab, etc.
- Ability to work at a laboratory bench or fume hood for extended periods of time.
- Ability to work with hazardous or flammable materials (e.g. chemicals, electrical equipment) so as not to endanger oneself or others.
- 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.
- Ability to frequently and accurately communicate with employees, customers, and vendors in person, via the telephone or by email.
- Constant walking or motion to coordinate work and interact with co-workers.
- Regularly sets up, adjusts, assembles, controls, tests, positions and operates objects and equipment weighing up to 20 pounds.
- Ability to lift up to 40 pounds for approximately 10% 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 comply with any applicable personal protective equipment requirements.
- Ability and means to travel between Madison locations.
- Ability to travel 20% of working time away from work location, may include overnight/weekend travel.
- Bachelor’s degree in Life Sciences, or related field; or high school degree/general education diploma and 4 years of relevant experience in lieu of degree.
- 10+ years of management experience in a clinical laboratory or high volume laboratory environment.
- 10+ years experience managing in a CLIA/CAP environment.
- 5+ Hands-on experience in molecular biology techniques.
- Basic computer skills to include Internet navigation, Email usage, and Microsoft Office.
- Authorization to work in the United States without sponsorship.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Working knowledge of molecular diagnostics.
- ASCP certification or a clinical board certification.
- Master’s degree or PhD in Life Sciences, or related field.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.
Meet Some of Exact Sciences's Employees
Andrea A.Supervisor, Provider Support
Andrea has grown a career at Exact Sciences from specialist to supervisor on the Provider Support team. Her team delivers high quality customer service by assisting providers with product orders and providing field representatives with in-depth answers to questions received in the field.
Alice H.Specimen Processing Lead
As a Specimen Processing Lead, Alice manages and prioritizes workflow in the laboratory in order to deliver quality samples for testing—and participates in the interview and hiring process for her department. Since filming, Alice has been promoted to Clinical Laboratory Quality Assurance Associate.
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