Senior Scientist, R&D Design Transfer & Product Development
About this role
About the Role The Senior Scientist, R&D Design Transfer & Product Development will lead the transition of In Vitro Diagnostic (IVD) Next-Generation Sequencing (NGS) assays from R&D to Operations, ensuring strict compliance with regulatory and quality standards. The role balances hands-on laboratory work, data analysis, and meticulous documentation, and requires cross-functional collaboration to drive design transfer activities to completion. What You'll Do
- Plan and execute design transfer activities for IVD NGS assays transitioning from R&D to Operations.
- Plan and execute process validations (IQ/OQ/PQ).
- Design Transfer & Validation: ensure documentation of activities and maintain compliance with regulatory and quality standards.
- Balance hands-on laboratory work with data analysis and documentation.
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