Scientist, IVD BioDevelopment

Natera • Austin, TX

9h • $98,300 - $122,900

About The Position

Natera R&D is seeking a highly motivated Scientist to join its assay development team. The role works with cross-functional teams to develop laboratory tests that support patients and the business, and helps improve and expand Natera’s oncology product portfolio. The Scientist plans, executes, analyzes, and leads scientific studies under design control in a regulated environment, with substantial independence from the manager.

The position focuses on moderate- to high-complexity experiments and development, verification, and validation studies. It includes coordinating study design and analysis with biostatistics and bioinformatics, characterizing analytical performance in accordance with CLSI guidance, and preparing quality and design-control documentation for production implementation. The Scientist also communicates project progress and risks, documents work in an Electronic Quality Management System, and provides training and technical guidance to junior colleagues and laboratory operations.

Requirements

• A bachelor's degree in molecular biology, cellular biology, immunology, or a related field and 5–8 years of related experience; or a master's degree and 4 or more years of related experience; or a Ph.D. and 2 or more years of related experience.
• Knowledge of high-throughput NGS workflows or other clinical genetic testing applications.
• 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 collaborative and individual projects.
• Knowledge of design verification and validation processes compliant with U.S. and E.U. regulatory standards, including FDA, IVDR, ISO 13485, and ISO 14971.

Nice To Haves

• Hands-on expertise in NGS workflows, such as DNA extraction and whole-exome or whole-genome library preparation, and/or expertise with DNA molecular biology techniques such as PCR, qPCR, and multiplex PCR.
• Experience developing and validating molecular assays for IVD and CLIA laboratory testing.

Responsibilities

• Lead in-laboratory efforts and perform duties largely independently from the manager.
• Plan, execute, analyze, and present data from moderate- to high-complexity experiments.
• Troubleshoot experiments and conduct 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 using tools such as Excel and 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, including design inputs and outputs and risk assessments per ISO 14971, in line with CLIA, CAP, 21 CFR Part 820/QMSR, and ISO 13485.
• Communicate progress, outcomes, risks, and next steps to colleagues and senior management at laboratory and department meetings.
• Document research progress in 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.
• Lead multiple studies and laboratory priorities while maintaining targeted timelines, and perform other duties as assigned.
• Complete required HIPAA/PHI privacy, General Policies and Procedure Compliance, and security training within the first 30 days of hire, and maintain current status on Natera training requirements.

Benefits

• Comprehensive medical, dental, vision, life, and disability plans for eligible employees and their dependents.
• Free testing for employees and their immediate families.
• Fertility care benefits.
• Pregnancy and baby bonding leave.
• 401(k) benefits.
• Commuter benefits.
• Employee referral program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior