Associate Director Science & Technology (m/f/d)
Core
Lead the creation of analytical data packages for drug-device combination products, specifically injectables like biologics and radio-ligands in autoinjectors or needle-safety devices.
Role type
Senior Expert - Medical Device Analytical Representative (Drug-Device Combination Products)
Builds
Analytical data packages, stability strategies, and regulatory documents for combination products
Domain
Pharmaceutical manufacturing, Chemistry Manufacturing Control (CMC), Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Combination product development, parenteral analytical development, cGMP, ISO standards, statistical data analysis, method validation and transfer, regulatory document review, project leadership
Preferred skills
Global matrix environment experience, outsourcing strategy management, cross-functional collaboration
Technologies
Minitab
Responsibilities
Coordinate project-specific analytical tasks for functional/mechanical attributes from component to final product; select and manage testing laboratories and CROs; own drug-specific analytical methods and parameter sheets; co-author CMC strategies and stability protocols; support product registrations; perform statistical data analysis to justify device specifications
Seniority
Senior, hands-on IC with leadership experience
