CMC Scientist (m/w/d)
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Bern, Schweiz |
Temporary Employment
Job title: CMC Scientist (m/w/d)
Industry: PharmaSkills: CMC,Drug Development,QbD
Start of project: 01.05.2024
Duration of the project : 6 months
Tasks:
- Run small Expert Teams to compile Quality by Design and regulatory dossier information
- Compile Quality by Design information
- Compile CMC regulatory dossier information & PACMP protocols / reports
- Enable/direct internal department digital improvement initiatives encompassing: interactive training material, global portals, project reporting tools and dashboards, process flow data mapping.
- Provide project coordinator support for CMC project teams and internal department improvement and strategy/innovation initiatives
Qualifications:
- 5+ years experience in the pharmaceutical industry (plasma, recombinant molecules, cell & gene therapy) or other high technology areas (MedTech, electronics)
- Project coordination/leadership; enjoys leading teams to achieve quality results in a defined timeframe.
- QbD, process development, scale-up, technology transfer, process validation, CMC regulatory affairs, and / or MS&T
- A digital expertise with hands-on experience focussed on advanced data management / data processing / data analytics in a life sciences area
- Have experience in interpreting, visualizing and communicating complex project data to facilitate collaborative decision-making driving cross-functional business outcomes
- Knowledge of regulatory activities and trends, experience with health authority, i.e., FDA, EMA, PDMA, is a definite plus
Referenznummer: 14488
Branche: Pharma
Beginn des Projekts: 01.05.2024
Dauer: 6
Anstellungsart: Temporary Employment
Kontakt
Lars Uhl