Senior Scientist, R&D Design Transfer & Product Development

Natera
Austin
Workplace: OnsiteFull timeUSD 136,600 - 170,700Function: Research & Scientific (R&D)Education: phdSkills: ["Cross-functional communication","Interpersonal skills","Data analysis","Basic statistical analysis","Time management","Organizational skills","Root cause analysis"]

Lead the transfer of IVD next-generation sequencing assays from R&D to Operations by planning, executing, and documenting design transfer activities. Own process validations, stability studies, and test method validation, and support the creation of manufacturing specifications and Design History Files/Device Master Records. Drive risk management, change control, CAPA/root-cause investigations, and cross-functional execution while ensuring compliance with FDA/ISO 13485/CLSI standards in GLP/GMP environments.

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FursaFursa
Natera
Natera
2 days ago

Senior Scientist, R&D Design Transfer & Product Development

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Source: Company careers pageValidated by: Fursa AI
Last checked: 17 hours agoStatus: Live

Job Summary

Lead the transfer of IVD next-generation sequencing assays from R&D to Operations by planning, executing, and documenting design transfer activities. Own process validations, stability studies, and test method validation, and support the creation of manufacturing specifications and Design History Files/Device Master Records. Drive risk management, change control, CAPA/root-cause investigations, and cross-functional execution while ensuring compliance with FDA/ISO 13485/CLSI standards in GLP/GMP environments.
Location: Austin
Workplace: Onsite
Employment Type: Full time
Job Function: Research & Scientific (R&D)
Seniority: Mid level

Key Responsibilities

  • •Lead and support transition of IVD NGS assays from R&D to Operations by planning, executing, and documenting design transfer activities to completion.
  • •Plan and execute process validations (IQ/OQ/PQ), stability studies, and study protocols; perform data analysis and author final reports.
  • •Support test method development, characterization, and Test Method Validation (TMV), including generation of manufacturing specifications.
  • •Lead risk management (including FMEAs), and establish/maintain Design History Files (DHF) and Device Master Records (DMR).
  • •Lead change control impact evaluation and manage CAPA/troubleshooting by investigating deviations and performing root cause analysis.

Pay and Benefits

Salary: USD 136,600 - 170,700
Perks:Health InsuranceDentalVision401kPaid Leave

Key Requirements

  • •PhD in molecular biology, cell biology, biotechnology, biochemistry, or related field with 4+ years relevant industry experience, or Master’s with 7+ years, or Bachelor’s with 10+ years.
  • •Hands-on expertise in next-generation sequencing (NGS) workflows such as DNA/RNA extraction, targeted enrichment, and/or whole genome library preparation, plus expertise in DNA molecular biology techniques (PCR, qPCR, multiplex PCR).
  • •Ability to own studies end-to-end: design experiments, execute in the lab, analyze data, and document results, including basic statistical analysis.
  • •Strong knowledge of design controls, quality management systems (QMS), and regulatory standards (FDA, ISO 13485, CLSI) within GLP/GMP environments; study plan/protocol/report authoring desired.
  • •Excellent cross-functional communication and time management/organizational skills to balance multiple priorities and complete deliverables.
Experience:Molecular biologyNext-generation sequencing (NGS)IVD product developmentGLP/GMPDesign controlsQuality management systems (QMS)
Education:PhD / Doctorate in Molecular Biology, Cell Biology, Biotechnology, Biochemistry, or a related scientific field
Skills:Cross-functional communicationInterpersonal skillsData analysisBasic statistical analysisTime managementOrganizational skillsRoot cause analysis
Languages:English
Tech Stack:NGSDNA/RNA extractionTargeted enrichmentWhole genome library preparationPCRQPCRMultiplex PCRJMPFMEAIQ/OQ/PQDHFDMRFMEAsCAPA

Company Brief

Natera
Develops and commercializes genetic testing and diagnostics focused on reproductive health, oncology, and organ transplant to inform clinical decision-making and improve patient outcomes.
Industry: Diagnostics
Company Size: Enterprise (1,001+ employees)
Revenue: USD 500M to 1B
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: San Carlos, United States
Founded: 2004
WebsiteLinkedIn