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.
- Interface with multiple functional groups to drive project deliverables in a dynamic, fast-paced environment. What We're Looking For
- Experience leading design transfer of assays from R&D to Operations, preferably in the IVD/NGS space.
- Demonstrated ability to plan and execute IQ/OQ/PQ validations.
- Strong knowledge of regulatory and quality standards applicable to IVDs (e.g., GMP/GLP) and a track record of compliant documentation.
- Hands-on laboratory experience combined with data analysis and strong documentation skills.
- Proven cross-functional collaboration and communication to drive projects to completion.