IVD BioDevelopment Scientist — NGS & cfDNA Innovation

Natera; Austin (TX); On-site; USD 98,000 - 123,000; Full time

Benefits offered by this job

Competitive Benefits

Job summary

Natera is seeking a Scientist to join the R&D assay development team in Austin, TX. You will develop and validate cfDNA-based assays, lead projects with cross-functional biologists, engineers, and biostatisticians, and ensure design control and regulatory compliance throughout the product development cycle.

The ideal candidate has strong molecular biology expertise, hands-on NGS experience, and a track record of delivering robust assays for regulated environments such as CLIA and ISO standards.

Qualifications

• Requires bachelor’s degree and 5–8 years of related experience or MS with 4+ years or PhD with 2+ years.
• Experience developing and validating molecular assays for IVD/CLIA lab testing preferred.
• Knowledge of design verification/validation per FDA/IVDR, ISO 13485 and ISO 14971.

Responsibilities

• Lead in-lab efforts with minimal supervision.
• Plan, execute, analyze, and present moderate- to high-complexity experiments; troubleshoot root causes.
• Coordinate study design, sample size justification, acceptance criteria, and analysis with biostatistics and bioinformatics; perform basic data analysis.
• Characterize analytical performance studies following CLSI guidance.
• Author/review SOPs and reports; contribute to design control deliverables per CLIA/CAP/21 CFR 820.

Skills

NGS workflows

Data analysis

Cross-functional collaboration

Communication

Education

Bachelor’s degree in molecular/ cellular biology or related

MS degree in related field

PhD in related field

Tools

Excel

JMP

Job description

Natera is seeking a Scientist to join the R&D assay development team in Austin, TX. You will develop and validate cfDNA-based assays, lead projects with cross-functional biologists, engineers, and biostatisticians, and ensure design control and regulatory compliance throughout the product development cycle.

The ideal candidate has strong molecular biology expertise, hands-on NGS experience, and a track record of delivering robust assays for regulated environments such as CLIA and ISO standards.