Design Transfer Scientist
Core
Lead the transition of market-leading In Vitro Diagnostic (IVD) Next-Generation Sequencing (NGS) assays from R&D into scalable clinical operations, bridging molecular biology with manufacturing execution.
Role type
Senior IC Design Transfer Scientist (IVD/NGS)
Builds
Production-ready protocols and scalable clinical operations for IVD NGS assays
Domain
Life sciences / Clinical diagnostics / Next-Generation Sequencing
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), molecular biology techniques (PCR, hybrid capture), Design Controls, Quality Management Systems (QMS), regulatory standards (FDA, ISO 13485, CLSI), statistical analysis (Minitab, JMP), automated liquid handling platforms (Hamilton, Tecan)
Preferred skills
IVD product development, scale-up, manufacturing, commercial Quality Control (QC)
Technologies
Minitab, JMP, Hamilton, Tecan
Responsibilities
Execute process validations, stability studies, and study protocols; Support test method development, characterization, and Test Method Validation (TMV); Lead risk management activities including FMEAs; Manage change control workflows; Investigate product or process deviations and implement CAPA; Coordinate with internal groups (automation engineering, lab ops, bioinformatics, statistics, project/product management); Partner with Supply Chain for raw material pipelines
Seniority
Senior, hands-on IC