Cmc Scientist and Digital Enabler - Zurich, Schweiz - Swisslinx

Swisslinx

Geprüftes Unternehmen

Zurich, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

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