Senior Scientist, Combination Product Characterization (Onsite)
Core
Hands-on device characterization and design scientist focusing on pre-filled syringe and auto injector combination product development to identify device failure risks and improvement opportunities.
Role type
Senior Scientist, Combination Product Characterization
Builds
Drug delivery device technology platforms for the company's pipeline
Domain
Biopharmaceuticals / Medical Devices / Mechanical Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Optical imaging, mechanical testing, 3D CAD, geometric tolerancing, stack-up analysis, FMEA, analytical method development, prototype testing, Python programming
Preferred skills
Design Controls (21 CFR 820.30), ISO 13485, ISO 14971, EU MDR, IEC 62304, ISO 11608, FDA Guidance for Container Closure Systems
Technologies
Solidworks, X-ray computed tomography, rheometry, microscopy, Python
Responsibilities
Technical interrogation of drug delivery device technology platforms, leveraging analytical instruments and in silico modeling, collaborating with QA and CROs, liaising with external vendors/manufacturers, communicating complex mechanical engineering information to cross-functional teams
Seniority
Senior, hands-on IC
