Senior Research Associate — FDA-Ready NGS Assay Development

Natera; San Francisco (CA); On-site; USD 109,000 - 136,000; Full time

Benefits offered by this job

401(k) with company match

Generous paid time off

Wellness and work-life benefits

Job summary

Natera, a global cfDNA leader, seeks a Senior Research Associate to advance NGS-based assays and support FDA submissions within a CLIA laboratory setting. You will collaborate across regulatory, QA, automation, bioinformatics, and product teams to ensure high-quality, scalable assays and robust verification activities.

The role requires strong molecular biology expertise, data analysis skills (JMP/Excel/Python/R), and experience in design controls for IVD products in a fast-paced environment.

Qualifications

• Bachelor’s degree in molecular biology, genetics, biochemistry, cell biology, or related field with 4+ years industry experience, or MS with 2+ years in a research/assay development setting.
• Experience with IVD product development and design controls.
• Experience in NGS-based assay development under design control and for FDA submission.
• Experience in regulated CLIA/CAP laboratory environments.

Responsibilities

• Design, develop, and validate automated high-throughput NGS assays for FDA submission and CLIA lab use.
• Implement assigned technical projects and timelines for NGS-based assays.
• Design and execute moderate to high complexity experiments and perform basic data analysis (JMP, Excel).
• Collaborate with assay development scientists on assay specs, reagents, equipment and quality metrics.
• Work with Clinical Laboratory and QA to ensure methods meet quality standards.
• Coordinate with automation engineering, lab operations, bioinformatics, statistics, and product management to drive projects.
• Write project protocols, reports and SOPs; train lab personnel.
• Plan and execute verification activities.
• Identify areas for continuous improvement to shorten turnaround times.

Skills

Molecular biology

Data analysis

Python or R

Liquid handler

Team collaboration

Communication

CLIA/CAP

Education

Bachelor's degree in Molecular Biology

Master's degree in Molecular Biology

Tools

JMP

Excel

Python

R

Liquid handling robots

Job description

Natera, a global cfDNA leader, seeks a Senior Research Associate to advance NGS-based assays and support FDA submissions within a CLIA laboratory setting. You will collaborate across regulatory, QA, automation, bioinformatics, and product teams to ensure high-quality, scalable assays and robust verification activities.

The role requires strong molecular biology expertise, data analysis skills (JMP/Excel/Python/R), and experience in design controls for IVD products in a fast-paced environment.