Manager - Physicochemical Characterization, Mass Spectrometry
Current
Hannover, Lower Saxony, Germany
- leading a team of 6 in the field of mass spectrometry analysis for biologic/biosimilar products (incl. on-line liquid chromatography)
- developed and established new analytical LC-MS methods for 6+ biologic/biosimilar products
- conducted 15+ forced degradation and stability studies for various biologic/biosimilar products
- established critical parameters of various biologic/biosimilar products that we identified via forced degradation and stability studies, and partly guided dossier content
- 2 products reached marked approval (FDA and EMA) with methods designed and data derived from our team
- gained broad insight into overall biopharmaceutical development (CLD, USP, DSP, DPD), enabling me to provide valuable information, insight, and strategy