IVD NGS Scientist: Product Development & Verification

Natera; San Carlos (CA); On-site; USD 117,000 - 146,000; Full time

Benefits offered by this job

Annual performance incentive bonus

Long-term equity awards

Comprehensive health benefits

401(k) with company match

Generous paid time off and holidays

Wellness and work-life benefits

Job summary

Natera is a global leader in cfDNA testing, focused on oncology, women's health and organ health. We seek a Scientist to optimize processes and run verification studies within the Early Cancer Detection product development team, collaborating with scientists across functions to deliver high-quality clinical assays.

You will design and validate high-throughput NGS assays, manage projects, mentor junior staff, and ensure CLIA/CAP and FDA submission readiness in a fast-paced environment.

Qualifications

• BA/BS with 5+ years experience, MS with 3+ years or PhD with 1+ years 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.

Responsibilities

• Design, develop, and validate automated high-throughput NGS assays that will be submitted to FDA and regulatory bodies, and be run in a commercial single-site IVD CLIA laboratory.
• Manage assigned technical projects and associated timelines and deliverables in 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 other assay development scientists on the specifications of assay, reagent, equipment and quality metrics for future production assays.
• Work with Clinical Laboratory and Quality Assurance to ensure that developed methods meet Natera’s rigorous quality standards.
• Coordinate with multiple internal groups (automation engineering, laboratory operations, bioinformatics, statistics, project and product management) and serve as point person to ensure the successful identification andtimely execution of projects.
• Write project protocols, reports and SOPs and train lab operations clinical lab scientists on procedures.
• Plan and execute verification activities.
• Identify areas for continuous improvement and actively contribute to the effort of introducing better practices to improve production workflows and shorten TAT for patient samples.

Skills

NGS assay development

Design control

Cross-functional collaboration

Statistical design/analysis

Python or R

JMP

Excel

Automation/robotics

CLIA/CAP experience

Documentation & SOPs

Education

Bachelor's degree in Life Sciences

MS or PhD in a related field

Tools

JMP

Excel

Python

R

Liquid handler robots

Automation software

Job description

Natera is a global leader in cfDNA testing, focused on oncology, women's health and organ health. We seek a Scientist to optimize processes and run verification studies within the Early Cancer Detection product development team, collaborating with scientists across functions to deliver high-quality clinical assays.

You will design and validate high-throughput NGS assays, manage projects, mentor junior staff, and ensure CLIA/CAP and FDA submission readiness in a fast-paced environment.