Scientist, IVD BioDevelopment

Scientist, IVD BioDevelopment

Position Summary

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