Senior Scientist, R&D Design Transfer & Product Development

Natera
Austin
Workplace: OnsiteFull timeUSD 115,800 - 144,700Function: Research & Scientific (R&D)Experience: 4+ yearsEducation: mastersSkills: ["Cross-functional communication","Interpersonal communication","Time management","Organizational skills","Data documentation"]

Lead and support the transition of IVD Next-Generation Sequencing (NGS) assays from R&D to Operations by planning, executing, and documenting design transfer activities. Own process validations, stability studies, and test method validation while ensuring strict regulatory and quality compliance. Perform data analysis and reporting, drive risk management and change control, investigate deviations with root-cause analysis and CAPA, and partner cross-functionally—especially with Supply Chain—to deliver to completion.

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FursaFursa
Natera
Natera
3 months ago

Senior Scientist, R&D Design Transfer & Product Development

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Source: Company careers pageValidated by: Fursa AI
Last checked: 18 hours agoStatus: Live

Job Summary

Lead and support the transition of IVD Next-Generation Sequencing (NGS) assays from R&D to Operations by planning, executing, and documenting design transfer activities. Own process validations, stability studies, and test method validation while ensuring strict regulatory and quality compliance. Perform data analysis and reporting, drive risk management and change control, investigate deviations with root-cause analysis and CAPA, and partner cross-functionally—especially with Supply Chain—to deliver to completion.
Location: Austin
Workplace: Onsite
Employment Type: Full time
Job Function: Research & Scientific (R&D)
Seniority: Mid level

Key Responsibilities

  • •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 activities (including FMEAs) and maintain Design History Files (DHF) and Device Master Records (DMR).
  • •Lead change control to evaluate and determine the impact of design changes on on-market products.
  • •Investigate product or process deviations, perform root cause analysis, and implement CAPA; partner with Supply Chain to establish raw material and consumable pipelines and present technical status updates.

Pay and Benefits

Salary: USD 115,800 - 144,700
Perks:Health InsuranceDentalVisionLife InsuranceDisabilityFree TestingFertility Care401kCommuter BenefitsPregnancy LeaveParental LeaveReferral Program

Key Requirements

  • •PhD in Molecular Biology, Cell Biology, Biotechnology, Biochemistry, or related field with 4+ years of relevant industry experience (or Master’s with 7+ years, or Bachelor’s with 10+ years).
  • •Hands-on NGS workflow expertise (e.g., DNA/RNA extraction, targeted enrichment, or whole genome library preparation) and deep DNA molecular biology experience such as PCR, qPCR, or multiplex PCR.
  • •Ability to own studies end-to-end: design experiments, execute in the lab, analyze data, and document results, including basic statistical analysis.
  • •Knowledge of design controls, quality management systems (QMS), and regulatory standards (FDA, ISO 13485, CLSI) within GLP/GMP environments; GLP/GMP experience is highly desired.
  • •Experience authoring study plans/protocols/reports is highly desired; statistical software experience (such as JMP) is highly desired.
Experience:4+ yearsMolecular biologyNGSIVD product developmentGLP/GMP
Education:Master's in Molecular Biology, Cell Biology, Biotechnology, Biochemistry, or a related scientific field
Skills:Cross-functional communicationInterpersonal communicationTime managementOrganizational skillsData documentation
Languages:English
Tech Stack:NGSDNA extractionRNA extractionTargeted enrichmentWhole genome library preparationPCRQPCRMultiplex PCRJMPHamiltonTecanIQ/OQ/PQStability studiesFMEADHFDMRCAPAGLPGMPDesign History File (DHF)

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