Cmc Scientist and Digital Enabler

vor 2 Wochen

Zürich, Zürich, Schweiz Swisslinx Vollzeit

On behalf of our client, an international Biotechnology company based in Switzerland, Swisslinx is looking for a CMC Scientist and Digital Enabler.

This is initially a 12-months contract position (afterwards an extension for another year) with a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment.


  • Start date: 1st of July 2024
  • Duration: 12 months
  • Extension: possible
  • Workload: 100%
  • Remote work (you have to be based in Switzerland)

Your mission:

  • 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.

Your profile:

  • Educational background in Pharma
  • Large or Small Molecules or MedTech
  • 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, scaleup, technology transfer, process validation, CMC regulatory affairs, and / or MS&T
  • A digital expertise with handson experience focussed on advanced data management / data processing / data analytics in a life sciences area
  • Have experience in interpreting, visualising and communicating complex project data to facilitate collaborative decisionmaking driving crossfunctional business outcomes
  • Knowledge of regulatory actiivies and trends, experience with health authority, i.e., FDA, EMA, PDMA, is a definite plus
  • English: Spoken & excellent writing skills required; German: spoken & written is an asset

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