Role OverviewJoin Natera's Bio Development Team as a Design Transfer Scientist to lead the transition of our market-leading In Vitro Diagnostic (IVD) Next-Generation Sequencing (NGS) assays from R&D into scalable clinical operations.
What You Will Do
Own and execute process validations, stability studies, and study protocols, translating raw experimental data into final technical reports, and lead risk management activities, including FMEAs, to identify and mitigate potential product risks early.
Why It Might Be a Fit
The ideal candidate combines rigorous laboratory execution with robust data analysis and precise technical documentation to deliver production-ready protocols, and has experience with automated high-throughput NGS assays, molecular biology techniques, and regulatory standards (FDA, ISO 13485, CLSI).
Requirements
- BA/BS with 8+ years experience, MS with 5+ years or PhD with 3+ years experience in assay development and automation for the life science industry
- Experience with automated high-throughput NGS assays
- Hands-on expertise with Next-Generation Sequencing (NGS) workflows, including DNA/RNA extraction, targeted enrichment, or library preparation
- Direct experience executing molecular biology techniques such as nucleic acid extraction, PCR, NGS library preparation, and hybrid capture technologies
- Strong operational knowledge of Design Controls, Quality Management Systems (QMS), and regulatory standards (FDA, ISO 13485, CLSI) within regulated clinical diagnostic manufacturing environments
- Proven track record authoring comprehensive study plans, validation protocols, and technical reports
- Proficiency in statistical analysis with experience using specialized software such as Minitab or JMP
- Prior experience in IVD product development, scale-up, manufacturing, or commercial Quality Control (QC) is highly preferred
- Experience operating or optimizing automated liquid handling platforms (such as Hamilton or Tecan) is preferred
Benefits
- Annual performance incentive bonus
- Long-term equity awards
- Comprehensive health benefits (medical, dental, vision)
- 401(k) with company match
- Generous paid time off and company holidays
- Additional wellness and work-life benefits
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