Senior Scientist, GMP Analytical Services | Pharmacist (m/w/d)
Coriolis Pharma Research GmbH
Job Summary
This role is for a Senior Scientist specializing in GMP Analytical Services within a global contract research and development organization (CRDO) focused on biopharmaceuticals, including biologics, gene/cell therapies, and vaccines. The successful candidate will act as a subject matter expert, guiding complex customer projects within a GMP-regulated environment. Day-to-day responsibilities include leading analytical strategy, executing experiments using techniques like HPLC and particle analytics (DLS), and ensuring strict adherence to QA/QC processes, managing deviations, and handling OOS results. The position requires close collaboration with internal teams and clients worldwide, serving as a project leader overseeing planning, method implementation, data evaluation, and reporting, ultimately contributing to the development of innovative drugs and shaping the future of biopharmaceutical innovation.
Required Skills
Education
University degree in analytical chemistry, pharmaceutical sciences, (bio)chemistry, or a related field. PhD related to (U)HPLC method development or surfactant quantification is preferred.
Experience
- Minimum 5 years of industry experience (with PhD) in biopharmaceutical characterization by LC
- Minimum 9 years of industry experience (without PhD) in biopharmaceutical characterization by LC
- Professional experience in leading analytical strategy and experimental execution
- Professional experience in managing deviations, CAPAs, and change controls in a regulated environment
Languages
Additional
- Must ensure full adherence to QA and QC processes across all analytical activities in a GMP-regulated environment.
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