Senior Research Associate

Natera•San Carlos, CA

6d•$108,600 - $135,700

About The Position

Natera is seeking a highly motivated Senior Research Associate with a strong focus on process optimization and product verification studies to join the Early Cancer Detection product development team. This role involves developing and advancing Natera’s oncology product portfolio, working with internal cross-functional teams to develop IVD products. The ideal candidate will possess broad knowledge of molecular biology and chemistry, apply statistical principles to experiment design and analysis, have an in-depth understanding of design control methods, and experience with current NGS oncology diagnostics devices. The Senior RA will be a meticulous and proactive professional experienced in NGS-based assay development under design control for regulatory submissions, capable of working effectively in a fast-paced environment to ensure the development and launch of high-quality clinical assays.

Requirements

Bachelor’s degree in molecular biology, genetics, biochemistry, cell biology, or related field with 4+ years if relevant industry or M.S. degree in molecular biology or related field with a minimum of 2+ years of relevant industry experience in a research and/or assay development setting.
Experience with IVD product development and design controls.
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 with high-throughput automated assays utilizing liquid handler robots
Strong individual contributor as well as dedicated team player
Experience executing studies including stability, guard banding, reproducibility and repeatability.
Experience working in a regulated laboratory environment under CLIA/CAP
Data analysis (JMP and Excel) 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 submitted to FDA and regulatory bodies, and be run in a commercial single-site IVD CLIA laboratory.
Implement assigned technical projects and associated timelines and deliverables in NGS-based assays.
Design and execute moderate to high complexity experiments and perform basic data analysis (e.g. JMP, 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 identification and timely execution of projects.
Write project protocols, reports and SOPs and train lab operations clinical lab scientists on procedures.
Plan and execute 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.