Design Transfer Scientist

Natera•San Carlos, CA

4d•$116,160 - $145,200

About The Position

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.

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
Exceptional organization skills to manage complex validation timelines and drive technical projects to successful completion

Nice To Haves

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

Responsibilities

Own and execute process validations, stability studies, and study protocols, translating raw experimental data into final technical reports
Support test method development, characterization, and Test Method Validation (TMV) to generate accurate manufacturing specifications
Lead risk management activities, including FMEAs, to identify and mitigate potential product risks early
Manage change control workflows to evaluate and document the operational impact of design changes on on-market products
Investigate product or process deviations, perform rigorous root cause analysis, and implement sustainable Corrective and Preventive Actions (CAPA)
Coordinate with multiple internal groups (automation engineering, laboratory operations, bioinformatics, statistics, project and product management) and serve as point person to ensure the successful identification and timely execution of projects
Partner directly with Supply Chain to establish reliable raw material and consumable pipelines
Communicate complex technical updates, data-driven proposals, and project status clearly to cross-functional stakeholders across the business