Senior Scientist, R&D Design Transfer & Product Development
Core
Lead the transition of In Vitro Diagnostic (IVD) Next-Generation Sequencing (NGS) assays from R&D to Operations, ensuring compliance with regulatory and quality standards.
Role type
Senior Scientist, Design Transfer & Product Development
Builds
IVD NGS assays for oncology, women's health, and organ health diagnostics
Domain
Medical Diagnostics / Molecular Biology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
NGS workflows (DNA/RNA extraction, targeted enrichment, library preparation), PCR/qPCR/multiplex PCR, experimental design, data analysis, statistical analysis, risk management (FMEA), change control, CAPA, root cause analysis
Preferred skills
Design Controls/QMS knowledge (FDA, ISO 13485, CLSI), study protocol authoring, JMP statistical software, IVD product development, manufacturing scale-up, automated liquid handling (Hamilton, Tecan)
Technologies
NGS platforms, PCR instruments, automated liquid handling systems (Hamilton, Tecan), JMP
Responsibilities
Plan and execute process validations (IQ/OQ/PQ) and stability studies; Support test method development and validation; Lead risk management activities and maintain Design History Files; Lead change control for on-market products; Investigate deviations and implement CAPA; Partner with Supply Chain and present technical data to stakeholders
Seniority
Senior, hands-on IC