Senior Scientist, Assay Development
Core
Design, develop, and optimize robust multiomics molecular diagnostic assays for in vitro diagnostic (IVD) applications for early cancer detection.
Role type
Senior Scientist, Assay Development
Builds
Regulated diagnostic products for early cancer detection
Domain
Healthcare diagnostics / Genomics / Liquid biopsies
Deliverable
production ML models | product features
Required skills
NGS assay development, liquid biopsies, design of experiments (DOE), assay optimization, Design Control framework knowledge, analytical problem solving
Preferred skills
multiomics assays, cfDNA or fragmentomics-based assays, PMA submissions
Technologies
Next-Generation Sequencing (NGS)
Responsibilities
Design and optimize assay/reagent/quality-control parameters; Execute analytical validation and design verification studies; Collaborate with R&D, Lab Operations, Biostatisticians, and Quality/Regulatory teams; Draft study protocols and reports; Contribute to FDA PMA submission packages; Prepare data summaries for design reviews; Provide technical guidance and mentorship to associate scientists
Seniority
Senior, hands-on IC
