Senior QC Analytical Scientist | Senior QC Analytical Scientist
Amicus Organisation für Arbeit und Personal GmbH
Job Summary
This Senior QC Analytical Scientist role is a central technical position within the QC Analytical Expertise & Transfer group, focusing on analytical transfers, method validation, and life-cycle management for biopharmaceutical products. The scientist acts as the key analytical function for Quality Control, collaborating closely with QA, R&D, Production, Regulatory, and external partners. Core responsibilities include coordinating and executing analytical transfers into QC, defining transfer and validation strategies, and ensuring rigorous compliance with regulatory requirements (ICH, FDA, EMA). Day-to-day tasks involve assessing method performance through trend and risk analyses, providing expert support for method-related deviations, and maintaining essential documentation like SOPs and validation master plans. This position requires a highly structured, decisive professional with strong communication skills and a high sense of responsibility in a regulated biopharma environment.
Required Skills
Education
Degree in Natural Sciences or Engineering; or Vocational training (e.g., Laboratory Assistant, Technician, Master Craftsman) with relevant experience.
Experience
- Professional experience in the development, optimization, or transfer of analytical methods
- Experience in managing multiple parallel topics or projects
- Profound experience in drug testing (if vocational background)
Languages
Additional
- Fixed-term contract duration; Must assume responsibility for testing confirmation according to §14 AMWHV (German Drug and Active Pharmaceutical Ingredient Manufacturing Ordinance).
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