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15929en
- Contract
- English
- Associate
- Research & Development
- Zurich, Geneva, Luzern, Zug, Bern
- Healthcare & Life Sciences
Skills
CMC, QbD, Quality by Design, PACMP protocols, PACMP reports, Process development, Scale-up, Technology Transfer, Process validation, MS&T
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This vacancy has now expired
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, 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, visualising and communicating complex project data to facilitate collaborative decision-making driving cross-functional 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
For further information or to apply please do not hesitate to contact Alina Peeva, Senior Recruiter: alina.peeva@swisslinx.com
- 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, 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, visualising and communicating complex project data to facilitate collaborative decision-making driving cross-functional 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
For further information or to apply please do not hesitate to contact Alina Peeva, Senior Recruiter: alina.peeva@swisslinx.com
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