Missions
1. Run small Expert Teams to compile Quality by Design and regulatory dossier information.
2. Compile Quality by Design information.
3. Compile CMC regulatory dossier information & PACMP protocols/reports.
4. Enable/direct internal department digital improvement initiatives encompassing interactive training material, global portals, project reporting tools and dashboards, process flow data mapping.
5. Provide project coordinator support for CMC project teams and internal department improvement and strategy/innovation initiatives.
Profil
1. 5+ years’ experience in the pharmaceutical industry (plasma, recombinant molecules, cell & gene therapy) or other high technology areas (MedTech, electronics).
2. Project coordination/leadership; enjoys leading teams to achieve quality results in a defined timeframe.
3. QbD process development, scale-up, technology transfer, process validation, CMC regulatory affairs, and/or MS&T.
4. A digital expertise with hands-on experience focused on advanced data management/data processing/data analytics in a life science area.
5. Experience in interpreting, visualising and communicating complex project data to facilitate collaborative decision-making driving cross-functional business outcomes.
6. Knowledge of regulatory activities and trends, experience with health authority, i.e., FDA, EMA, PDMA, is a definite plus.
7. English spoken & excellent writing skills required.
8. German spoken & written is an asset.
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