natera
Design Transfer Scientist
At a Glance
- Location
- San Carlos, California, United States
- Employment
- employment_required
- Experience
- 8+ years
- Posted
- 2026-06-22T13:15:47-04:00
Key Requirements
Domain Knowledge
- Automation
- Clinical
- Manufacturing
- Medical
- Regulatory
Requirements
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
Responsibilities
Join 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.
This role bridges molecular biology with manufacturing execution, requiring an ownership mindset to build robust, compliant production pipelines that directly impact patient care.
The ideal candidate combines rigorous laboratory execution with robust data analysis and precise technical documentation to deliver production-ready protocols.
Own and execute process validations, stability studies, and study protocols, translating raw experimental data into final technical reports