Senior Design Transfer Scientist - NGS & IVD Development
Natera
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Benefits offered by this job
Job summary
Natera in California seeks a Senior Design Transfer Scientist to lead the transfer of IVD NGS assays from R&D to Operations, balancing hands-on lab work with data analysis and meticulous documentation in a fast-paced, regulated setting.
You will drive design transfer validation, TMV, DHF/DMR maintenance, change control and CAPA investigations, while collaborating cross-functionally to ensure supply chain readiness and on-market support.
Qualifications
- PhD with 4+ years of industry experience OR
- Master's with 7+ years experience OR
- Bachelor's with 10+ years experience in relevant field.
Responsibilities
- Plan and execute process validations (IQ/OQ/PQ) and stability studies.
- Support TMV development and generation of manufacturing specs.
- Lead Risk Management activities and maintain DHF/DMR.
- Lead change control and assess impact of design changes.
- Investigate deviations, perform root cause analysis, implement CAPA.
- Collaborate cross-functionally to establish material pipelines and present updates.
Skills
Education
Tools
Job description
Natera in California seeks a Senior Design Transfer Scientist to lead the transfer of IVD NGS assays from R&D to Operations, balancing hands-on lab work with data analysis and meticulous documentation in a fast-paced, regulated setting.
You will drive design transfer validation, TMV, DHF/DMR maintenance, change control and CAPA investigations, while collaborating cross-functionally to ensure supply chain readiness and on-market support.
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