This exempt position will play a key role in the day-to-day operation of the CareDx clinical laboratory operations. The Lab Manager oversees all phases of laboratory testing procedures and may also perform Clinical Lab Scientist (CLS) duties as needed. She/he will work with the quality team to ensure regulatory compliance, including clinical testing, validation of new products and processes from Research and Development and in-licensed partners, and represent the clinical laboratory on cross functional project teams. This position will administer proficiency, training, and competency assessment programs, and oversee the clinical laboratory occurrence management, non-conformance and CAPA processes. This position will serve as a General Supervisor under CLIA, California and NY as necessary to support technical and managerial oversight of the clinical laboratory.
- Manage the day-to-day operations of CareDx CLIA laboratory for clinical diagnostic testing, including proficiency testing, personnel, lab safety compliance, maintains lab operational workflow
- Collaborate with R&D and cross functional teams to support the technology transfer, operationalization, and optimization of our testing platform
- Managing and overseeing resources, hiring, training, and scheduling all employees
- Ensure all CareDx policies and procedures are followed, including CLIA and HIPAA requirements as necessary
- Work with the Quality team to maintain a Quality Management System that includes QC/QA, and regulatory compliance. Help design and maintain systems for tracking and improving process efficiency. Identify Quality events and change and control existing Quality documents as needed.
- Monitor the QA metrics, productivity, and attendance of all employees and for the testing platform
- Manage vendors and maintain strong external partnerships
- Provide day-to-day management of the team, including ownership for productivity, team development, coaching/mentoring of direct and indirect reports, performance review processes, daily staff briefings, and hands-on when necessary.
- Ensure that laboratory staff are fully trained and compliant with all CLIA, FDA, CAP, and other applicable state regulatory requirements.
- Bachelor’s degree in Molecular Biology, Biochemistry, Microbiology or Chemistry, or demonstrated equivalent experience required in addition to ASCP clinical lab scientist certification. Qualifications to serve as General and Technical Supervisor under CLIA, California and New York.
- Significant experience with molecular-based clinical testing methods, including NGS is required.
- Minimum of 3-5 years related experience in molecular based testing in a CLIA lab. Should have a working knowledge of CLIA, CAP, and New York quality system principles, concepts, systems, industry practices, and standards. Knowledge of FDA quality system regulations.
- Minimum of 1-2 years of supervisory or managerial experience in a CLIA lab environment and strong leadership skills to foster a high performance, teamwork-oriented laboratory environment.
- Strong interpersonal skills and high communication proficiency both verbal and written, in technical and non-technical domains. The desire and ability to communicate and mentor is a key component of the role.
- Familiarity with regulated clinical operation of laboratory instruments and applicable computer software.
- Good understanding of statistical methods and application to the analysis of complex molecular diagnostic assays.
- Demonstrated task leadership with timely achievement of goals.