Clinical Assay Specialist (CLIA)
Core
Provide technical and scientific oversight for CLIA laboratory testing, ensuring compliance with regulatory and quality standards, and lead assay transfers and validation activities.
Role type
Senior Clinical Assay Specialist (CLIA)
Builds
High-complexity diagnostic tests and Companion Diagnostic (CDx) programs
Domain
Clinical Laboratory / Diagnostics / Drug Development
Required skills
High-complexity testing, assay validation, quality control, regulatory compliance (CLIA/CAP), SOP development, troubleshooting, proficiency testing coordination, sample processing, instrumentation operation
Preferred skills
Laboratory supervision, LDT transfer, CDx development, ISO 15189/IVDR knowledge, ASCP certification
Technologies
IHC, PCR/qPCR, NGS, immunoassay (MSD-ECL), Laboratory Information Systems (LIS)
Responsibilities
Provide technical and scientific oversight for CLIA laboratory testing, Lead assay transfers and validation activities, Establish and monitor quality control processes, Troubleshoot technical and operational issues, Coordinate proficiency testing programs, Execute development and validation studies for Companion Diagnostic (CDx) programs
Seniority
Senior, hands-on IC with supervisory responsibilities