Clinical Assay Specialist & Technical Supervisor (CLIA) to join our team at
100 Perimeter Park Drive, Morrisville, NC.
Work Schedule- Monday - Friday, 8am - 5pm EST. Weekend work may be required.
Job Responsibilities- Provide technical and scientific oversight for CLIA laboratory testing, ensuring compliance with regulatory and quality standards.
- Supervise testing personnel, including training, competency assessments, and day-to-day support for high-complexity testing.
- Lead assay transfers, verifications, 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.
- Partners with cross-functional teams drive continuous improvement initiatives, workflow optimization, and operational efficiency.
- Support general laboratory operations, organization, and maintenance activities.
- 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 QualificationsU.S. Education Requirements:The incumbent must qualify as a CLIA high complexity Technical Supervisor (42 CFR [redacted]) and General Supervisor (42 CFR [redacted]) and must meet applicable CAP and New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) personnel requirements for these roles.
Technical Supervisor (high complexity) - must meet one of the following:- An earned bachelor's degree in chemical, physical, or biological science, or medical technology, from an accredited institution AND at least 4 years of experience in high complexity testing in an acceptable laboratory.
- An earned master's degree in a chemical, physical, biological, or clinical laboratory science, or medical technology, from an accredited institution AND at least 2 years of experience in high complexity testing in an acceptable laboratory; OR
- An earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution AND at least 1 year of experience in high complexity testing in an acceptable laboratory; OR
New York State (NYSDOH CLEP):- Meet all NYSDOH CLEP qualification requirements applicable to the Technical Supervisor and supervisory role for the relevant category or categories of service, 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 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).
- 2 or more years' experience supervising, training, or mentoring laboratory staff in a clinical setting preferred (to support supervisory growth of the role).
Preferred Qualifications- Current ASCP (or equivalent) certification; ASCP Specialist in Molecular Biology (SM/MB)
Additional Job Standards- 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.
- Companion diagnostics (CDx) or IVD development experience, ideally supporting pharmaceutical clinical trials.
- 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).
- Familiarity operating in a regulated device or clinical-study environment (e.g., ISO 15189, IVDR, 21 CFR Part 11, GCP/ICH E6, ISO 20916).
- 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.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan. For more detailed information, please click here.
