Design Transfer Scientist

Role: Design Transfer Scientist leading the transition of Natera's NGS-based IVD assays from R&D to scalable clinical manufacturing. Responsibilities: execute process validations, stability studies, and develop test methods; lead risk management activities such as FMEAs; manage change controls, investigate deviations, and implement CAPAs; collaborate with cross-functional teams including automation, bioinformatics, and supply chain to ensure robust production pipelines; communicate project status and technical updates. Requirements: BA/BS with 8+ years, MS with 5+ years, or PhD with 3+ years in assay development for life sciences; hands-on experience with NGS workflows, molecular biology techniques, and automated platforms; knowledge of Design Controls, QMS, regulatory standards (FDA, ISO 13485); proficient in data analysis and technical documentation. Preferred: experience in IVD product development, scale-up, manufacturing, or QC. HighValue: NGS assays, molecular biology, clinical diagnostic manufacturing, regulated environment (FDA, ISO), assay validation, process transfer, automation platforms. Collaboration: cross-functional internal teams and supply chain partners. Work Setup: not specified; likely on-site or hybrid, based on typical industry practices.