Core Tech Transfer Scientist
Core
Lead and assist technical transfer activities to facilitate process and product transfer into Operations for In Vitro Diagnostic (IVD) medical devices.
Role type
Technical Transfer Scientist (Manufacturing)
Builds
IVD medical device manufacturing processes and procedures
Domain
Healthcare / Medical Devices / Biotech Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, ISO13485 standards, FDA guidelines, process development, pilot scale manufacturing, process validation, root cause analysis, Quality System documentation, manufacturing training strategy
Preferred skills
statistical techniques (control charting, data trending, hypothesis testing), SAP ERP
Technologies
Microsoft Office Suite, SAP
Responsibilities
Develop and characterize moderately complex manufacturing processes; execute process development pilot scale manufacturing; support external design transfer of reagents/components; support Process and Test Method Validation readiness; assist in troubleshooting and root cause investigation; write and edit Quality System documents; develop manufacturing training strategies
Seniority
Mid-level, hands-on IC