Scientist, IVD BioDevelopment

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 a global leader in cell-free DNA testing. We measure tumor-derived cfDNA at the molecular level to help inform personalized health care decisions with a non-invasive test.

Natera R&D is seeking a highly motivated Scientist to join the rapidly growing assay development team to help build the future of Natera. In this position, you will work with high-performing cross-functional teams to develop laboratory tests that benefit our patients and the business. The ideal candidate has a deep understanding of molecular biology, strong scientific curiosity, demonstrated experience in developing Next Generation Sequencing (NGS) technologies and proven experience developing and validating assays through the product development cycle. You will plan, execute, and lead scientific studies under design control in a regulated environment, helping to improve and expand Natera’s oncology product portfolio.

Primary Responsibilities

• Leads in-laboratory efforts and performs duties largely independent from manager
• Plan, execute, analyze, and present data from moderate- to high-complexity experiments, including hands-on troubleshooting and root-cause analysis for development, verification and validation studies.
• Coordinate study design, sample size justification, acceptance criteria, and analysis with biostatistics and bioinformatics; perform basic data analysis (e.g., Excel, JMP)
• Characterize analytical performance studies following CLSI guidance
• Author and review SOPs, protocols, study reports, and transfer documents for production implementation; contribute to design control deliverables (design inputs/outputs, risk assessments per ISO 14971) in line with CLIA, CAP, 21 CFR Part 820/QMSR, and ISO 13485
• Communicates progress directly with colleagues and senior management. Provides regular updates, outcomes, risks, and next steps at laboratory and department meetings
• Documents research progress under an Electronic Quality Management System
• Train junior team members on new SOPs and laboratory workflows, and provide technical guidance and troubleshooting support to laboratory operations
• Be flexible to lead multiple studies and laboratory priorities while maintaining targeted timelines; perform other duties as assigned
• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
• Must maintain a current status on Natera training requirements

Qualifications

• Requires a university bachelor's degree (molecular biology, cellular biology, immunology, or a related) and a minimum of 5-8 years of related experience or a MS degree and 4+ years of related experience or a PhD and 2+ years of related experience

Knowledge, Skills, and Abilities

• Knowledge of high-throughput NGS workflows or other clinical genetic testing applications, required
• Hands-on expertise in Next-Generation Sequencing (NGS) workflows such as DNA extraction, whole exome or whole genome library preparation and/or expertise with various DNA molecular biology techniques such as PCR, qPCR and multiplex PCR, preferred
• Experience developing and validating molecular assays for IVD and CLIA laboratory testing strongly preferred
• Strong interpersonal, analytical, and problem-solving skills
• Exceptional communication and presentation skills with meticulous attention to detail
• A proactive, solutions-oriented mindset and demonstrated success in both collaborative and individual projects
• Knowledge of design verification/validation processes compliant with the U.S. and E.U. regulatory standards (FDA, IVDR), including ISO 13485 and ISO 14971

Austin, TX

$98,300 - $122,900 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!

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.

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

Please be advised that Natera will reach out to candidates with a @ natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

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As set forth in Natera’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

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