Associate Principal Scientist, Combination Product Design Verification (Associate Director Equivalent)
Core
Lead end-to-end design verification strategies, test method development, and validation for novel biologic/drug/vaccine-device combination products to ensure clinical readiness and commercialization.
Role type
Associate Principal Scientist (Associate Director Equivalent), hands-on IC with project leadership
Builds
Drug-device combination products for safe and effective delivery
Domain
Biopharmaceuticals / Medical Devices / Combination Product Development
Required skills
combination product design verification, test method development and validation, design controls, risk management, manufacturing process validation, regulatory submissions, cross-functional team leadership, analytical test method technology transfer, laboratory documentation practices, project management
Preferred skills
material characterization and failure mode analysis, stress-strain testing, analytical or numerical simulation, equipment procurement and upskilling
Technologies
ISO 11608, ISO 11040, ISO 80369, electronic documentation systems
Responsibilities
Lead design verification strategies and protocols for combination product programs; establish and validate test methodologies including accelerated and real-time aging studies; support critical validation activities like drug product filling and final assembly process validation; oversee external partner design verification activities; author and review regulatory submissions (INDs, IMPDs, NDAs, BLAs); lead clinical supplies production testing; communicate technical challenges and risks to senior leadership and external partners.
Seniority
Senior, hands-on IC with strategic project leadership
