Staff Scientist, IVD Product Development

Natera•San Carlos, CA

4h•$157,300 - $196,600•Onsite

About The Position

Natera is a global leader in cell-free DNA testing, measuring fetal, tumor, or donor cfDNA at the molecular level to help inform personalized health care decisions with a non-invasive test. The company is seeking a highly motivated Staff Scientist with a strong focus on reagent and process optimization to join the Early Cancer Detection product development team, which is tasked with developing and advancing Natera’s oncology product portfolio. This role involves working with internal cross-functional teams to develop IVD products. The ideal candidate is a driven professional with broad knowledge of molecular biology and chemistry, capable of applying statistical principles to experiment design and analysis. The Scientist should possess an in-depth understanding of design control methods and experience with current NGS oncology diagnostics devices. The position requires a meticulous and proactive scientist with experience in NGS-based assay development under design control, intended for submission to FDA and other regulatory bodies, who can work effectively in a fast-paced environment to ensure the highest quality clinical assays are developed and launched for patients.

Requirements

MS with 11+ years or PhD with 8+ years experience in assay development and automation for the life science industry
Demonstrated track record of development and validation of automated protocols for CLIA labs
Experience with IVD product development and design controls
Deep technical knowledge of NGS biology and processes
Strong understanding of the chemistry underlying nucleic acid extraction, PCR, NGS library preparation, and hybrid capture technologies
Hands-on experience in reagent preparation and quality control for NGS-based assays
Experience implementing, optimizing, and troubleshooting high-throughput automated assays utilizing liquid handler robots
Strong individual contributor as well as dedicated team player
Experience designing and executing studies including stability, guard banding, reproducibility and repeatability and QC method development
Data analysis (JMP) required
Excellent communication, organizational, record-keeping, planning, attention to detail and time management skills
Ability to manage multiple priorities in a fast-paced, dynamic environment and to collaborate cross-functionally with other groups (regulatory affairs, CLIA, LIMS, lab operations, QA, automation, research)

Nice To Haves

Coding skills (Python or R)
Liquid handler programming experience

Responsibilities

Design, develop and validate automated high-throughput NGS assays that will be run in a commercial CLIA laboratory
Manage assigned technical projects and associated timelines and deliverables in NGS-based assays
Mentor and manage the functional activities of junior employees
Design and execute moderate to high complexity experiments and perform data analysis (e.g. JMP, R, Excel)
Collaborate with other assay development scientists on the specifications of assay, reagent, equipment and quality metrics for future production assays
Work with Clinical Laboratory and Quality Assurance to ensure that developed methods meet Natera’s rigorous quality standards
Coordinate with multiple internal groups (automation engineering, laboratory operations, bioinformatics, statistics, project and product management) and serve as point person to ensure the successful and timely execution of projects
Write study protocols and reports and SOPs and train lab operations operators on protocols
Lead verification activities
Identify areas for continuous improvement and actively contribute to the effort of introducing better practices to improve production workflows and shorten TAT for patient samples
Ability to manage Scientists and Research Associates