Scientist, IVD Product Development

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 Scientist with a strong focus on process optimization and product verification studies to join the Early Cancer Detection product development team, joining a group of scientists who are tasked with developing and advancing Natera’s oncology product portfolio.

The Scientist 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 Scientist should have an in-depth understanding of design control methods and experience with current NGS oncology diagnostics devices.

We are looking for a meticulous and proactive scientist with experience in both NGS-based assay development under design control and meant for submission to FDA and other regulatory bodies and 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:

• 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.

• Manage assigned technical projects and associated timelines and deliverables in NGS-based assays. Mentor junior employees.

• 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.

Minimum Qualifications:

• BA/BS with 5+ years experience, MS with 3+ years or PhD with 1+ 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.

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 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

• 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)