Staff Scientist, New Product Development

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 Staff Scientist to join Nateras Oncology Product Development Team. We are looking for a seasoned candidate with experience in next generation sequencing (NGS) assay development who enjoys solving challenging and complex problems in a fast-paced environment. The ideal candidate is self-motivated and effectively works around unknowns to move the needle in the development, launch, and support of the highest quality clinical assays for our patients.

The Staff Scientist will be working with internal cross functional teams to develop, launch, and support LDT 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 candidate should have an in-depth understanding of product development and support in a CLIA environment, and experience with current NGS oncology diagnostics devices.

PRIMARY RESPONSIBILITIES:

• Design, develop, and validate automated high-throughput NGS assays that will be run in a commercial CLIA laboratory
• Provide production support to automated high-throughput NGS assays currently run in commercial CLIA laboratories
• 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, Python, Excel)
• Work with Clinical Laboratory and Quality Assurance to ensure that developed methods meet Nateras rigorous quality standards
• Coordinate with multiple internal groups (automation engineering, laboratory operations, bioinformatics, statistics, project and product management) and serve as point person/technical lead to ensure the successful and timely execution of projects
• Write study protocols, reports, and SOPs, train lab operations operators on protocols
• 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

QUALIFICATIONS:

• 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
• Well able to perform first-pass data analysis; strong ability to interpret experimental data
• Deep technical knowledge of NGS biology and processes

KNOWLEDGE, SKILLS, AND ABILITIES:

• Strong understanding of the chemistry underlying nucleic acid extraction, PCR, NGS library preparation, and hybrid capture technologies
• 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, Python, or R) required
• Excellent communication, organization, 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, CLIA, LIMS, automation, research, product)
• Able to travel to Nateras Austin site up to 20% of time