Scientist, IVD Product Development

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 cell-free DNA testing. We measure fetal, tumor, or donor cfDNA at the molecular level to help inform personalized health care decisions with a non-invasive test.

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, joining a group of scientists who are tasked with developing and advancing Natera’s oncology product portfolio.

The Scientist will be working with internal cross functional teams to develop IVD products. The ideal candidate is a driven professional who maintains broad knowledge of molecular biology and chemistry, and applies 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.

We are looking for a meticulous and proactive scientist with experience in both NGS-based assay development under design control and meant for submission to FDA and other regulatory bodies and who can work effectively in a fast-paced environment to ensure that the highest quality clinical assays are developed and launched for our patients.

Primary 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.

Minimum 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.

Knowledge, Skills, and Abilities

• 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 utilizing liquid handler robots
• Strong individual contributor as well as dedicated team player
• Experience designing and executing studies including stability, guard banding, reproducibility and repeatability and QC method development
• Experience working in a regulated laboratory environment under CLIA/CAP
• Data analysis (JMP and Excel) required, coding skills (Python or R), and liquid handler programming experience 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 to collaborate cross-functionally with other groups (regulatory affairs, CLIA, LIMS, lab operations QA, automation, research)

Compensation & Total Rewards

This range reflects a good-faith estimate of the base pay we reasonablyexpect to offer at the time of hire.Final compensation will vary based on experience, qualifications, and internal equity considerations.

This position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program, including:

• 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

Compensation Range

$116,800 — $146,000 USD

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

For more information, visit www.natera.com.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents.

Link: https://www.natera.com/notice-of-data-collection-california-residents/