Job DescriptionWe are seeking an experienced Clinical Laboratory Manager to lead the establishment and ongoing operation of a nascent high complexity CLIA laboratory specializing in ELISA-based measurement of a skeletal growth biomarker in infants and children. This individual will serve concurrently as both Technical Supervisor and General Supervisor, reporting directly to the CLIA Laboratory Director and Research Administrator. The role carries responsibility from pre-operational build-out through active licensure, with main responsibilities being daily laboratory operations, quality management, and regulatory compliance.
Key Responsibilities- Implement end-to-end CLIA-compliant testing workflows, from specimen receipt and accessioning through result reporting.
- Establish and maintain all required CLIA standard operating procedures (SOPs) and policies
- Conduct analytical validation studies for quantitative ELISA based testing
- Coordinate submission and maintenance of the CLIA certificate
- Establish and maintain a robust laboratory Quality Management System (QMS) aligned with CLIA requirements.
- Perform and/or supervise processing of patient specimens, including ELISA assay execution, and instrument operation.
- Prepare and present monthly quality monitoring reports to the Laboratory Director summarizing KPI performance, trends, and corrective/preventive actions
Minimum Qualifications- Doctoral degree (MD, DO, PhD, or equivalent) in chemical, physical, biological, or clinical laboratory science from an accredited institution, with at least one (1) year of training or experience performing high-complexity testing in biochemistry;
OR- Master's degree in chemical, physical, biological, or clinical laboratory science from an accredited institution, with at least two (2) years of laboratory training and/or experience, including a minimum of six (6) months performing high-complexity biochemistry testing.
Compensation is determined based on years of relevant experience and departmental equity.
