Scientist, IVD Product Development

Role: Process development scientist specializing in assay optimization and verification for Natera’s oncology cfDNA testing platform. Responsibilities: design, develop, and validate automated high-throughput NGS assays for FDA submission; manage projects, mentor junior staff; conduct experiments and data analysis; collaborate across teams to define assay specifications, ensure quality compliance, and improve workflows. Qualifications: BA/BS with 5+ years, MS with 3+ years, or PhD with 1+ year in assay development, automation, or related life sciences; proven experience with nucleic acid chemistry, NGS technologies, and CLIA laboratory practices; expertise in reagent prep, automation troubleshooting, and design control processes. Preferred: coding skills (Python/R), experience with liquid handling robots, and assay validation studies (stability, reproducibility). High-Value: focus on NGS-based assays for oncology, regulatory submission experience for IVD products, and working within regulated CLIA/CAP environments. Cross-functional collaboration includes automation engineering, bioinformatics, quality assurance, and clinical labs. Location: not specified. Travel: not indicated.