Associate Principal Scientist, Combination Product Design Verification (Associate Director Equivalent)
Core
Lead end-to-end design verification strategies and testing execution for novel biologic/drug/vaccine-device combination products to ensure clinical readiness and commercialization.
Role type
Associate Principal Scientist (Associate Director Equivalent), Combination Product Design Verification
Builds
Drug-device combination products for safe and effective delivery via inhalation, implantation, and injection routes.
Domain
Biopharmaceuticals / Medical Devices / Combination Product Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Combination product development, Design verification, Design controls, Risk management (DFMEA), Manufacturing process validation, Regulatory submissions (IND/NDA/BLA), Test method development and validation, Cross-functional project leadership, Materials & molding technologies, Analytical testing, Quality Management Systems (QMS)
Preferred skills
Mechanical engineering simulation, Material characterization, Stress-strain testing, 3D CAD (Solidworks), Rapid manufacturing, Human Factor Engineering, Commercialization strategy
Technologies
Instron, Zwick, Texture Analyzer, XRCT, Optical microscopy, Solidworks, 3D printing
Responsibilities
Lead design verification strategies and protocols for combination product programs; Define design inputs/outputs and validate test methodologies; Execute accelerated and real-time aging studies; Oversee external partner testing activities; Author regulatory submissions; Lead clinical supplies production testing; Collaborate with cross-functional teams on process validations.
Seniority
Senior, hands-on IC with strategic leadership
