Natera Scientist, IVD BioDevelopment at Natera leading assay development and validation in a regulated environment. Focus on molecular biology and Next Generation Sequencing technologies.
Responsibilities
Lead in-laboratory efforts independently
Plan, execute, analyze, and present data from complex experiments
Coordinate study design and analysis with biostatistics and bioinformatics
Characterize analytical performance studies following CLSI guidance
Author and review SOPs, protocols, study reports, and transfer documents
Contribute to design control deliverables in line with regulatory standards
Communicate progress with colleagues and senior management
Document research progress under an Electronic Quality Management System
Train junior team members and provide technical guidance
Manage multiple studies and laboratory priorities
Qualification
KnowledgeStrong interpersonalA proactive$98
Required
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
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.
$98,300—$122,900 USD
NateraTM 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.
