Design Transfer Scientist

POSITION SUMMARY:

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.

PRIMARY 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

QUALIFICATIONS:

• 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

KNOWLEDGE, SKILLS, AND ABILITIES:

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