Senior Research Associate

Role: Senior Research Associate focused on developing and validating NGS-based IVD assays for early cancer detection, aligning with FDA and regulatory standards. Responsibilities: design, optimize, and verify automated high-throughput NGS assays, coordinate with cross-functional teams including automation, bioinformatics, and quality assurance, and ensure compliance with CLIA/CAP regulations. Tasks include experimental design, data analysis, SOP creation, and continuous process improvement. Requirements: Bachelor’s in molecular biology, genetics, or related fields with 4+ years (or M.S. with 2+ years) industry experience in assay development; expertise in nucleic acid chemistry, NGS library prep, reagent QC, automated liquid handling; experience with regulated labs (CLIA/CAP); proficiency in data analysis tools (JMP, Excel, Python or R a plus). HighValue: molecular biology, NGS assay development, FDA submission readiness, regulated environment (CLIA/CAP), oncology diagnostics, automation. Collaboration: cross-team coordination across assay development, automation, bioinformatics, clinical labs, and quality. WorkSetup: not specified, but implies a lab and collaborative environment.