Beschreibung
Supports the technical development of packaging and drug delivery systems for oral drugs, from early phase through commercialization and production scale-up.
Tasks
- Support project planning and definition of product requirements for packaging and drug delivery systems
- Monitor and challenge technical development, test and verification work with external partners
- Provide primary packaging and device expertise in cross-functional drug product teams
- Support manufacturing of clinical material and production scale-up
- Support regulatory dossier development, review and submission
- Lead risk management activities and manage Human Factors Engineering
- Author technical documentation and ensure a high-quality Design History File
Profile
- Bachelor's or Master's degree in Packaging Science/Engineering, Mechanical Engineering or related engineering field
- At least 7 years experience supporting or leading pharmaceutical packaging or drug delivery device development
- Fluency in English required; German/French proficiency advantageous
- Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive, EU Medical Device Regulation)
- Experience in product design, design for manufacture, test and verification
- General understanding of Human Factors Engineering and risk management processes
Offer
- 3–6 months interim, then a permanent position
- Onsite in Basel
Company
Pharmaceutical development