The opportunity
Join Natera's Bio Development Team as a Design Transfer Scientist to lead the transition of our market-leading In Vitro Diagnostic (IVD) Next-Generation Sequencing (NGS) assays from R&D into scalable clinical operations. This role bridges molecular biology with manufacturing…
What you'll do
Own and execute process validations, stability studies, and study protocols,: translating raw experimental data into final technical reports
Support test method development, characterization, and Test Method Validation: (TMV) to generate accurate manufacturing specifications
Lead risk management activities, including FMEAs, to identify and mitigate potential product risks early
Manage change control workflows to evaluate and document the operational: impact of design changes on on-market products
Investigate product or process deviations, perform rigorous root cause: analysis, and implement sustainable Corrective and Preventive Actions (CAPA)
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
What they're looking for
- Partner directly with Supply Chain to establish reliable raw material and consumable pipelines
- Communicate complex technical updates, data-driven proposals, and project: status clearly to cross-functional stakeholders across the business
- 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 automated high-throughput NGS assays
