Biberach an der Riß, Baden-Württemberg, Germany
- Protein chemist with extensive experience in biopharmaceutical development and protein characterization. - Responsible for reaching a "well characterized" status for recombinant proteins in clinical development, with special emphasis on critical quality attributes (cQA) assessment and quality by design (QbD). - Provide scientific leadership and coordinate departmental activities at different stages of development, manufacturability assessment, IND, phase I-III clinical trials, BLA, post-approval commitments. - Provide CMC expertize to support regulatory filings of biopharmaceuticals and succesful interactions with health authorities. - Responsible for driving cross-functional CMC development strategies for key drug development projects, including early to late stage and major post-launch improvement program Specialties: Analytical development of therapeutic proteins. CMC strategy for successful regulatory filings of biopharmaceuticals