Senior Scientist, R&D Design Transfer & Product Development
Natera· Bio Development
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
More open roles at Natera
- Enterprise Strategic Accounts Manager4d agoHybrid (Chicago–Milwaukee–Madison triangle) · Women's Health Sales
- Staff Scientist R&D4d agoSan Carlos, CA · Molecular Biology Informatics & Statistics
- Clinical Oncology Specialist, GU4d agoPittsburgh, PA · Oncology Sales
- Clinical Oncology Specialist, Breast4d agoHybrid (Dallas / Fort Worth) · Oncology Sales
- Account Sales Representative4d agoHybrid (Modesto, CA; San Jose, CA) · Women's Health Sales