Clinical Assay Specialist (CLIA)

Job Responsibilities

• Provide technical and scientific oversight for CLIA laboratory testing, ensuring compliance with regulatory and quality standards.
• Serve as General Supervisor and Technical Supervisor designee as applicable for the CLIA lab, including oversight and execution of testing, training, competency assessments, and day-to-day support for high-complexity testing.
• Lead assay transfers and validation activities to support clinical laboratory operations.
• Establish, monitor, and improve quality control processes to ensure accurate and reliable test results.
• Troubleshoot technical and operational issues, implement corrective actions, and ensure testing systems meet performance requirements.
• Coordinate proficiency testing programs and support laboratory readiness for CAP, CLIA, NYSDOH, and other regulatory inspections.
• Partner with cross-functional teams drive continuous improvement initiatives, workflow optimization, and operational efficiency.
• Execute development and validation studies for Companion Diagnostic (CDx) programs under the direction of project leads.
• Provide direct technical support for CDx development activities, including sample processing, instrumentation, data generation, and troubleshooting.
• Contribute to the preparation and review of SOPs, validation protocols, reports, and technical documentation.

Minimum Qualifications

U.S. Education Requirements: The incumbent must qualify as a CLIA high complexity General Supervisor (42 CFR 493.1461) and must meet applicable CAP and New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) personnel requirements for this role.

General Supervisor (high complexity) - must meet one of the following: An earned bachelor’s degree in a chemical, biological, clinical or medical laboratory science, or medical technology, from an accredited institution AND at least 1 year of laboratory training or experience, or both, in high complexity testing; OR An earned associate degree in a laboratory science or medical laboratory technology from an accredited institution (or equivalent education and training as defined in 42 CFR 493.1489(b)(3)) AND at least 2 years of laboratory training or experience, or both, in high complexity testing; OR A doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry AND at least 1 year of laboratory training or experience, or both, in high complexity testing.

New York State (NYSDOH CLEP): Meet all NYSDOH CLEP qualification requirements applicable to the General Supervisor, as determined by NYSDOH. New York requirements may be more stringent than federal CLIA, and final acceptance of an individual is subject to NYSDOH review. For testing samples originating in New York, on-site supervision is always required whenever such testing is performed.

Work Experience Required: 4 or more years’ experience with firsthand high complexity testing across one or more relevant platforms (e.g., IHC, PCR/qPCR, NGS, immunoassay) preferred. 2 or more years’ experience supervising, training, or mentoring laboratory staff in a clinical setting preferred (to support supervisory growth of the role).

Work Experience Preferred

• Direct experience establishing, activating, or accrediting a CLIA laboratory, or bringing a laboratory through CAP accreditation and/or New York State (NYSDOH CLEP) approval.
• Experience transferring and validating laboratory-developed tests (LDTs) or companion diagnostic assays from an R&D or development environment into a CLIA/clinical laboratory.
• Experience authoring and implementing SOPs, quality systems, and QC programs.
• Hands-on experience across one or more of the laboratory's platforms: IHC, PCR/qPCR, NGS, and/or immunoassay (MSD-ECL).
• Companion diagnostics (CDx) or IVD development experience, ideally supporting pharmaceutical clinical trials.
• Familiarity operating in a regulated device or clinical-study environment (e.g., ISO 15189, IVDR, 21 CFR Part 11, GCP/ICH E6, ISO 20916).

Preferred Qualifications

Current ASCP (or equivalent) certification; ASCP Specialist in Molecular Biology (SM/MB)

Additional Job Standards

• Theoretical and practical knowledge of analytical instrumentation.
• Knowledge of preclinical/clinical assays and companion diagnostics (CDx) development.
• Strong working knowledge of CLIA, CAP, and relevant state regulations.
• Proficiency with Laboratory Information Systems (LIS) and Microsoft Office.
• Excellent problem-solving and critical-thinking skills; ability to multitask and manage priorities in a demanding environment.
• Strong written and verbal communication skills; skilled in time management, planning, and delivering presentations.
• May work with potentially hazardous/biohazardous materials, clinical or laboratory environment with exposure to biohazard materials.
• Must be able to see and distinguish colors.
• Must have command of the English language, both oral and written.
• Must be able to use hands to finger, handle, or touch objects, tools, or controls, including a keyboard, for up to 12 hours per day.
• Must be able to stand, walk, and/or bend for up to 12 hours per day and perform repetitive tasks; occasionally lifting up to 40 lbs.
• Mandatory use of personal protective equipment (lab coats, gloves, safety glasses) always in laboratory areas.