Scientist, IVD Product Development

About the role

We are looking for a highly motivated Scientist with a strong focus on process optimization and product verification studies to join the Early Cancer Detection product development team. This role involves working with internal cross-functional teams to develop IVD products, advancing Natera’s oncology product portfolio through molecular-level cell-free DNA testing.

The ideal candidate is a driven professional with broad knowledge of molecular biology and chemistry, applying statistical principles to experiment design and analysis. The Scientist should have an in-depth understanding of design control methods and experience with current NGS oncology diagnostics devices.

Responsibilities

• Design, develop, and validate automated high-throughput NGS assays for submission to the FDA and other regulatory bodies, to be run in a commercial single-site IVD CLIA laboratory.
• Manage assigned technical projects, including timelines and deliverables for NGS-based assays.
• 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 assays, reagents, equipment, and quality metrics for future production assays.
• Work with Clinical Laboratory and Quality Assurance to ensure developed methods meet Natera’s rigorous quality standards.
• Coordinate with multiple internal groups (automation engineering, laboratory operations, bioinformatics, statistics, project and product management) to ensure timely execution of projects.
• Write project protocols, reports, and SOPs, and train lab operations and clinical lab scientists on procedures.
• Plan and execute verification activities.
• Identify areas for continuous improvement and contribute to better practices to improve production workflows and shorten turnaround time (TAT) for patient samples.

Requirements

• BA/BS with 5+ years, MS with 3+ years, or PhD with 1+ years of experience in assay development and automation for the life science industry.
• Demonstrated track record of development and validation of automated protocols for CLIA labs.
• Experience with IVD product development and design controls.

Skills

• Strong understanding of the chemistry underlying nucleic acid extraction, PCR, NGS library preparation, and hybrid capture technologies.
• Hands-on experience in reagent preparation and quality control for NGS-based assays.
• Experience implementing, optimizing, and troubleshooting high-throughput automated assays using liquid handler robots.
• Ability to work as both a strong individual contributor and a dedicated team player.
• Experience designing and executing studies including stability, guard banding, reproducibility, repeatability, and QC method development.
• Experience working in a regulated laboratory environment under CLIA/CAP.
• Data analysis skills (JMP and Excel required; Python or R, and liquid handler programming are a plus).
• Excellent communication, organizational, record-keeping, planning, attention to detail, and time management skills.
• Ability to manage multiple priorities in a fast-paced, dynamic environment and collaborate cross-functionally with groups such as regulatory affairs, CLIA, LIMS, lab operations, QA, automation, and research.

Benefits

• Annual performance incentive bonus.
• Long-term equity awards.
• Comprehensive health benefits (medical, dental, vision).
• 401(k) with company match.
• Generous paid time off and company holidays.
• Additional wellness and work-life benefits.
• Free testing for Natera employees and their immediate families, plus fertility care benefits.
• Pregnancy and baby bonding leave.
• Commuter benefits.
• Generous employee referral program.

Pay

Compensation range: $116,800—$146,000 USD. Final compensation will vary based on experience, qualifications, and internal equity considerations.