Dr. Tim Seiffert

CMC & Manufacturing Strategies for UCB's small and large molecule pipeline. Industrial LCM

CMC development for small molecules (API, Drug Product and Analytical). Industrialization of manufacturing processes and commercial product support in lifecycle management.

Define and implement manufacturing & sourcing strategies for API. Transfer API processes from development to industrialization. CMO management

Leading the CMC project management organization, overall responsibility for project management of all technical project activities in the area of CMC development for the UCB drug development pipeline (NCEs and NBEs)

CMC Project Manager in Drug development. Management of all CMC related drug development activities from candidate selection to submission and launch for assigned projects.

Drug substance analysis, stability testing, analytical development, “drugability” screening of early development candidates, physicochemical and solid state characterization, preformulation. Analytical support of chemistry group. Head of quality control drug substance within development

Drug substance analysis, stability testing, analytical development and physicochemical characterisation. QC release for APIs in development. Characterization of preclinical formulations.

Analytical development/characterization for drug substances (NCEs and proteins/peptides) and drug products (tablets, patches and protein/peptide formulations). Protein and peptide analysis. Support to biotechnological process development. Development/Characterization of biodegradable polymers.

Analytical development and method validation for drug substances and drug products. Stability and QC testing of drug substances and drug products.

Analytical Chemistry