Senior QC Analytical Scientist | Senior QC Analytical Scientist
Amicus Organisation für Arbeit und Personal GmbH
Job Summary
The Senior QC Analytical Scientist will join the QC Analytical Expertise & Transfer group, taking on a central technical role focused on analytical transfers, method validation, and the life-cycle management of biopharmaceutical products. Daily tasks involve coordinating and executing analytical transfers from R&D into QC, defining transfer and validation strategies, and ensuring method validation adheres to stringent regulatory standards (ICH, FDA, EMA). This role requires acting as a key analytical function, collaborating closely with QA, MSAT/R&D, Production, and external partners. The scientist will also manage reference standards and cell banks, support audits and inspections, and provide technical expertise for method-related deviations and complex analytical issues. This is a project-based role until November 30, 2026, requiring strong analytical skills, regulatory knowledge, and the ability to manage multiple parallel projects in a highly regulated QC environment.
Required Skills
Education
University degree in natural sciences or engineering, or professional training (e.g., laboratory technician, technician, master craftsman) with profound experience in drug testing.
Experience
- Demonstrated experience in the development, optimization, or transfer of analytical methods
- Professional experience in managing multiple parallel topics or projects
- Professional experience with complex analytical data interpretation
- Professional experience with regulatory requirements (FDA, EMA, ICH)
Languages
Additional
- Appointment of testing confirmation according to §14 AMWHV (German Drug and Active Pharmaceutical Ingredient Manufacturing Ordinance); Fixed-term contract until November 30, 2026.
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