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 Scientist within the Molecular Biology product development team to join a cross-functional team of scientists who are tasked with developing and advancing Natera’s oncology product portfolio.
The Scientist will be working with internal cross functional teams and investigating the feasibility of applying a variety of scientific principles and concepts to oncology diagnostics and monitoring space. The ideal candidate is a driven professional who maintains broad knowledge of state-of-the-art principles and theories with an in-depth understanding of applicability to oncology research.
We are looking for a meticulous and dedicated scientist with experience in both NGS assay development and high throughput automation that can work effectively in a fast-paced environment to ensure that the highest quality clinical assays are developed and launched for our patients.

QUALIFICATIONS:

• BA/BS with 7 years experience, MS with 4 years or PhD with at least 3 years experience in assay development and automation for the Molecular Diagnostic industry
• Demonstrated track record of development and validation of automated protocols for CLIA labs

KNOWLEDGE, SKILLS, AND ABILITIES:

• Experience developing, implementing, optimizing, and troubleshooting high-throughput automated assays utilizing liquid handler robots
• 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
• Strong individual contributor as well as dedicated team player
• Experience designing and executing studies including stability, guard banding, reproducibility and repeatability, and validation
• Experience working in a regulated laboratory environment under CLIA/CAP, NYSDOH, IVD is a plus
• Data analysis, coding skills (Python or R), and automation liquid handler programming experience are a plus
• Excellent communication, organizational, record-keeping, planning, attention to detail and time management skills
• Ability to collaborate cross-functionally with other groups (CLIA, LIMS, lab operations QA, Automation, Research & Development)

• Lead technical projects and associated timelines and deliverables in NGS-based assays as a subject matter expert. Represent the bio development group in cross-functional project teams
• Design, develop, and validate automated high-throughput NGS assays that will be run in a commercial CLIA laboratory
• Mentor junior employees
• Design and execute high complexity experiments and perform data analysis (e.g. Excel, Python, and R)
• Collaborate with assay development scientists on the specifications of assay, reagent, equipment and quality metrics for existing and 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 (laboratory operations, automation engineering, bioinformatics, statistics, project and product management) and serve as point person to ensure the successful identification and timely execution of projects
• Write documentation and SOPs, and train lab operations operators on protocols. Oversee validation activities
• Participate in post-launch surveillance by troubleshooting production issues, performing root cause analysis on automation, reagent, peripheral equipment and assay failures
• 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