Drug-device combination product analytical data packages
Functional attributes of drug-device combination products
Plan resource & budget for your project(s)
Lead the creation of strong analytical data-packages for drug-device combination products as a member of the global CMC analytical and device sub teams
Job Summary
Lead the creation of strong analytical data-packages for drug-device combination products as a member of the global CMC analytical and device sub teams.
Plan resources and budget, select testing laboratories, and manage outsourced analytical project activities at CROs.
Co-shape and co-author x-functional analytical CMC strategies and documents, contributing to regulatory submissions and product registrations.
Matching Summary
Lead the creation of strong analytical data-packages for drug-device combination products as a member of the global CMC analytical and device sub teams.
Salary
Base: € 65,605.54/year; Bonus/Equity: attractive incentive program; Benefits: modern company pension scheme, childcare facilities, learning and development opportunities
Skills & Requirements
Must-have
drug-device combination product analytical data packages
functional attributes of drug-device combination products
plan resource & budget for your project(s)
lead outsourced analytical project activities
define, organise, document AM/PS validation and transfer
co-author x-functional analytical CMC strategies
Nice-to-have
collaborative spirit
self-driven attitude
high level of learning agility
flexible and remote working
Key Requirements
Master or PhD in engineering or chemical/bio analytics
working experience in pharmaceutical industry in combination product development
Proven knowledge in late phase parenteral analytical development
leadership experience in managing development projects
understanding and awareness of regulatory guidelines for combination product analytics