Sysmex Inostics Inc offers innovative blood-based molecular diagnostic tests to improve cancer, molecular characterization to better inform patient treatment options and clinical management. Sysmex Inostics Inc is headquartered and having CLIA laboratory in Baltimore, Maryland.
The Laboratory Director will join the team to provide clinical and technical functions for CLIA regulated high complexity clinical laboratory liquid biopsy NGS and digital PCR molecular testing.
The Laboratory Director is responsible for the overall compliance and operation of Sysmex Inostics’ CLIA Laboratory in Baltimore, Maryland, including the employment of personnel who are qualified and competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for ensuring compliance with the applicable regulations and accreditation requirements. The Laboratory Director may delegate certain responsibilities to other properly trained staff, but will have full responsibility to ensure that all delegated duties are properly performed. The Laboratory Director will be report to the CEO at Sysmex Inostics Inc.
Essential Duties and Responsibilities:
1. Provide leadership with respect to patient safety and quality, laboratory test utilization, and operational performance of the laboratories.
2. Responsible for maintaining existing and developing new elements of a compliant quality system for clinical laboratory testing
3. Review assay QC data for all assays which report data to clients (clinical patient testing, clinical trials and research studies)
4. Demonstrate and apply strong technical knowledge and accompanying understanding of clinical implementation for all validated assays in Sysmex Inostics’ CLIA laboratory
5. Lead Laboratory Staff to ensure timely and accurate result reporting
6. Ensure test performance for pre-analytic, analytic, and post-analytic methods and that verification/validation procedures are adequate to determine the accuracy, precision and other pertinent performance characteristics of the methods.
7. Review method performance documentation including specifications and data summaries and approve via attestation.
8. Oversee testing personnel and monitor all work performed to ensure that testing and reporting of results is performed promptly, accurately, and proficiently, and to ensure that analytically and clinically valid, medically reliable data are generated. Interact with the R&D teams to provide insights for new test development and process improvements.
Physical Risk:Regular exposure to risk that may require alertness, but with minimal precautions.
Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.
Percent of Travel: 10%
• M.D. or Ph.D. in a Biological Science and at least 5 years of experience directing a molecular diagnostics laboratory, including experience in the Armed Forces
• The Laboratory Director shall satisfy the applicable requirements in New York State Public Health Law for a New York State clinical laboratory permit as described in:
o New York State, Title 10, NYCRR, Part 19: Clinical Laboratory Directors
• The Laboratory Director will have or be eligible to obtain a New York State Certificate of Qualification in Oncology, Molecular and Cellular Tumor Markers
o American Board of Pathology (dual certification in either anatomic or clinical pathology and molecular genetic pathology)
• M.D. must be licensed and currently in good standing registered to practice medicine in Maryland
• Extensive experience in complex diagnostic molecular testing techniques, including hands-on experience with Next-Generation Sequencing assays.
Apply to this Position
• Proven experience and/or compliance with clinical molecular assay design, validation, and implementation under CLIA, CAP and State of New York Department of Health, and other regulatory agencies.