The role is responsible for formulation design and process development across various modalities, with a focus on ADCs, within the Formulation Technology Research Laboratories (FTRL). Responsibilities include supporting the preparation of regulatory submissions (e.g., NDA, BLA, and post-approval changes) as well as manufacturing technology transfer to commercial sites. The role also drives the exploration and evaluation of new technologies within FTRL and serves as an integral contributor to decision-making processes in the Formulation Technology Research Laboratories * Plan, lead, and implement product development projects within the Formulation Technology Research Laboratories (FTRL). * Lead manufacturing technology transfer activities, primarily to Daiichi Sankyo Europe and CDMOs in the EU, as well as pivotal formulation development.
mehr