Senior Scientist, R&D Design Transfer & Product Development
A hands-on R&D scientist role at Natera leading the transfer of next-generation sequencing (NGS) in vitro diagnostic assays from R&D into manufacturing operations. Day to day involves planning and executing process validations (IQ/OQ/PQ), stability studies, risk management (FMEAs), CAPA troubleshooting, and authoring protocols and reports, using molecular biology techniques, statistical analysis,
- Compensation
- $136.6K–$170.7K / yr
- Location
- San Carlos, CA
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Not specified
- Experience
- 4+ years
- Category
- Design
- Posted
Skills
Must have
- PhD in Molecular Biology, Cell Biology, Biotechnology, Biochemistry, or related field with 4+ years industry experience; OR Master's with 7+ years; OR Bachelor's with 10+ years
- Hands-on expertise in NGS workflows (DNA/RNA extraction, targeted enrichment, whole genome library prep) and/or deep expertise in PCR, qPCR, multiplex PCR
- Ability to own a study end to end: designing experiments, executing in the lab, analyzing data, documenting results, with basic statistical analysis
- Excellent cross-functional communication and interpersonal skills; able to present complex technical data to non-technical audiences
- Exceptional time management and organizational skills; balance multiple priorities and drive deliverables to completion
Nice to have
- Knowledge of Design Controls, QMS, and regulatory standards (FDA, ISO 13485, CLSI) within GLP/GMP environments
- Experience authoring study plans, protocols, and study reports
- Experience with statistical software (such as JMP)
- Prior experience in IVD product development or commercialization
- Experience in manufacturing, scale up, and Quality Control (QC)
- Experience with automated liquid handling platforms (e.g., Hamilton, Tecan)
Full description
POSITION SUMMARY:
The Senior Design Transfer Scientist will lead and support the transition of In Vitro Diagnostic (IVD) Next-Generation Sequencing (NGS) assays from R&D to Operations. This role is responsible for planning, executing, and documenting all design transfer activities while ensuring strict compliance with regulatory and quality standards. The ideal candidate will balance hands-on laboratory work, data analysis, and documentation. As a cross-functional collaborator, you will interface with multiple functional groups to drive project deliverables to completion in a dynamic, fast-paced environment.
PRIMARY 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
EDUCATION & EXPERIENCE:
- PhD. in Molecular Biology, Cell Biology, Biotechnology, Biochemistry, or a related scientific field with 4+ years of relevant industry experience; OR
- Master’s degree in the fields above with 7+ years of relevant industry experience; OR
- Bachelor’s degree in the fields above with 10+ years of relevant industry experience
QUALIFICATIONS:
- Molecular Biology Experience: hands-on expertise in Next-Generation Sequencing (NGS) workflows such as DNA/RNA extraction, targeted enrichment, or whole genome library preparation and/or deep expertise with other DNA molecular biology techniques such as PCR, qPCR and multiplex PCR
- Experimental & Analytical Skills: Ability to own a study from start to finish including designing experiments, executing in the lab, analyzing data and documenting results. Must be able to perform basic statistical analysis.