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Posted Apr 20Senior Scientist, IVD Product Development
at Natera
San Carlos, United StatesHybrid
Responsibilities
- Design, develop and validate automated high-throughput NGS assays that will be run in a commercial CLIA laboratory
- 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 basic data analysis (e.g. JMP, R, Excel)
- Collaborate with other assay development scientists on the specifications of assay, reagent, equipment and quality metrics for future production assays
- 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 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
- Demonstrated track record of development and validation of automated protocols for CLIA labs •
Requirements
- 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.
- 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:
- BA/BS with 8+ years experience, MS with 5+ years or PhD with 3+ years
- experience in assay development and automation for the life science industry
- 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