Senior Research Associate, Product Development at Natera · San Carlos

POSITION SUMMARY: 

Natera is a global leader in cell-free DNA testing. We measure fetal, tumor, or donor cfDNA at the molecular level to help inform personalized health care decisions with a non-invasive test.

We are looking for 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 involved in advancing Natera’s oncology product portfolio.

The Senior RA will be working with internal cross functional teams to develop IVD products. The ideal candidate is a driven professional who maintains broad knowledge of molecular biology and chemistry, and applies statistical principles to experiment design and analysis. The Senior RA should have an in-depth understanding of design control methods and experience with current NGS oncology diagnostics devices. 

We are looking for a driven and rigorous Senior RA with experience in both NGS-based assay development under design control,  specifically for submission to FDA and other regulatory bodies,  who can work effectively in a fast-paced environment to ensure that the highest quality clinical assays are developed and launched for our patients.

PRIMARY RESPONSIBILITIES:

• Contribute to the design, development, and validation of  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 maintaining strict adherence to timelines and deliverable schedules
• Design, plan, 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) planning and executing workflow processes 
• 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

QUALIFICATIONS:

• Bachelor’s degree in molecular biology, genetics, biochemistry, cell biology, or related field with 4+ years of relevant industry experience 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

KNOWLEDGE, SKILLS, AND ABILITIES:

• 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, guardbanding, reproducibility and repeatability.
• Experience working in a regulated laboratory environment under CLIA/CAP
• Data analysis (JMP and Excel) required, coding skills (Python or R), and liquid handler programming experience are a plus
• 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)