Scientist, IVD Product Development

Natera
United States
Workplace: OnsiteFull timeUSD 116,800 - 146,000 annuallyFunction: Research & Scientific (R&D)Experience: 1+ yearsEducation: bachelorsSkills: ["Communication","Organizational","Record-keeping","Attention to detail","Time management"]

Develop and validate automated high-throughput NGS assays for IVD product development, including verification and submission-ready documentation under design control. Lead moderate- to high-complexity experiments and analyze data to support assay performance and quality metrics. Collaborate across automation, lab operations, bioinformatics, statistics, and project/product management, partnering with clinical laboratory and QA to ensure rigorous standards for CLIA laboratory execution and ongoing continuous improvement.

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FursaFursa
Natera
Natera
1 day ago

Scientist, IVD Product Development

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Last checked: 1 hour agoStatus: Live

Job Summary

Develop and validate automated high-throughput NGS assays for IVD product development, including verification and submission-ready documentation under design control. Lead moderate- to high-complexity experiments and analyze data to support assay performance and quality metrics. Collaborate across automation, lab operations, bioinformatics, statistics, and project/product management, partnering with clinical laboratory and QA to ensure rigorous standards for CLIA laboratory execution and ongoing continuous improvement.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: Research & Scientific (R&D)
Seniority: Mid level

Key Responsibilities

  • •Design, develop, and validate automated high-throughput NGS assays for submission to FDA and regulatory bodies, run in a commercial single-site IVD CLIA laboratory.
  • •Manage NGS assay technical projects, timelines, and deliverables, and mentor junior employees.
  • •Design and execute moderate to high complexity experiments and perform basic data analysis (e.g., JMP, Excel).
  • •Collaborate with assay development scientists to define specifications for assay, reagents, equipment, and quality metrics for future production assays.
  • •Coordinate with clinical laboratory and quality assurance to ensure methods meet quality standards; write protocols/reports/SOPs and train lab operations on procedures.

Pay and Benefits

Salary: USD 116,800 - 146,000 annually
Equity and Bonus:Equity
Perks:Health InsuranceDentalVision401kPaid Leave

Key Requirements

  • •BA/BS with 5+ years, or MS with 3+ years, or PhD with 1+ years in assay development and automation for the life science industry.
  • •Experience developing and validating automated protocols for CLIA labs, with IVD product development and design controls.
  • •Strong knowledge of nucleic acid extraction, PCR, NGS library preparation, and hybrid capture technologies.
  • •Experience designing and executing studies such as stability, guard banding, reproducibility, repeatability, and QC method development.
  • •Knowledge of regulated laboratory work under CLIA/CAP and ability to perform data analysis using JMP and Excel (Python or R is a plus).
Experience:1+ yearsLife sciencesIVDNGSCLIARegulated diagnostics
Education:Bachelor's in Bio Development
Skills:CommunicationOrganizationalRecord-keepingAttention to detailTime management
Tech Stack:NGSPCRHybrid captureLiquid handler robotsJMPExcelPythonRCLIACAPLIMSNGS library preparation

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