Scientist, IVD BioDevelopment

Natera • Austin, TX

14d

About The Position

Natera is seeking a Scientist to join its assay development team and help develop laboratory tests for its oncology product portfolio. The role works with cross-functional teams and involves planning, executing, and leading scientific studies under design control in a regulated environment. The scientist leads laboratory efforts largely independently, conducts experiments and analytical performance studies, documents work through an Electronic Quality Management System, and supports the development, verification, validation, and production transfer of assays. The position also includes communicating study progress and risks, training junior team members, and balancing multiple studies and laboratory priorities.

Requirements

• 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 PhD 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 and meticulous attention to detail.
• 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 is strongly preferred.

Responsibilities

• Lead laboratory efforts and perform duties largely independently from the manager.
• Plan, execute, analyze, and present data from moderate- to high-complexity experiments; troubleshoot 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 in accordance with ISO 14971 and applicable regulatory and quality standards.
• 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 SOPs and laboratory workflows, and provide technical guidance and troubleshooting support to laboratory operations.
• Lead multiple studies and laboratory priorities while maintaining targeted timelines; 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 training status.

Benefits

• Comprehensive medical, dental, vision, life, and disability plans for eligible employees and their dependents.
• Free testing for Natera 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: Mid Level