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. Backed by Lightspeed and Sequoia.
About the role
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.
What they're looking for
- 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
- Communication : Excellent cross-functional communication and interpersonal skills, with a proven ability to present complex technical data clearly to non-technical audiences
- Execution : Exceptional time management and organizational skills, with a demonstrated ability to balance multiple priorities and drive deliverables to completion
- Knowledge of Design Controls, Quality Management Systems (QMS), and regulatory standards (FDA, ISO 13485, CLSI) within GLP/GMP environments is highly desired
More about this role
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.
- 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...
Browse similar: Startup jobs