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Senior Scientist, R&D Design Transfer & Product Development

Natera· Bio Development
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San Carlos, CA$136.6k - $170.7kFull-timePosted 1mo ago

About the role

Senior Design Transfer Scientist responsible for leading and supporting the transfer of IVD NGS assays from R&D to Operations, including planning, executing, and documenting design transfer activities with regulatory and quality compliance.

Responsibilities

  • Design Transfer & Validation: Plan and execute process validations (IQ/OQ/PQ), stability studies, and study protocols; perform data analysis and author final reports
  • Test Method Development: Support test method development, characterization, and Test Method Validation (TMV), including the generation of manufacturing specifications
  • Quality & Risk Management: Lead Risk Management activities (including FMEAs) to identify and mitigate product risks; establish and maintain Design History Files (DHF) and Device Master Records (DMR)
  • Sustaining & Change Control: Lead change control activities to evaluate and determine the impact of design changes to on-market products
  • CAPA & Troubleshooting: Investigate product or process deviations, perform root cause analysis, and implement Corrective and Preventive Actions (CAPA)
  • Cross-Functional Collaboration: Partner with Supply Chain to establish raw material and consumable pipelines; present status updates, data, and technical proposals to cross-functional stakeholders

Qualifications

  • PhD in Molecular Biology, Cell Biology, Biotechnology, Biochemistry, or related field with 4+ years of relevant industry experience; OR
  • Master’s degree with 7+ years of relevant industry experience; OR
  • Bachelor’s degree with 10+ years of relevant industry experience

Skills

Required:NGS workflowsMolecular biology techniquesStudy design & data analysisCommunication
Nice to have:Regulatory & quality systems

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
Last updated Sep 10, 2026. Interested? Apply on the company site.

About Natera

A global leader in cfDNA testing

Dedicated to oncology, women’s health, and organ health. Natera’s cell-free DNA tests help protect health and inform more personalized decisions about care.

oncologywomen's healthorgan healthcell-free DNA

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