Drug Product Lead (all genders) - permanent, fulltime

You will lead and represent the Drug Product (DP) team for a product and being responsible for defining and executing the activities of drug product development, lifecycle management, and the technical-scientific support of the commercial production according to the latest state of science and technology, while considering regulatory requirements for the manufacturing of pharmaceuticals in parenteral drug product development.

Your responsibilities are: 

• Lead and represent the Drug Product (DP) team for a late-stage development and or a commercial product
• Drive Tech Transfers to commercial DP manufacturing sites
• Provide technical leadership in exception and change management
• Represent manufacturing, CCS and Formulation aspects in the PDS&T CMC Team
• Develop, manage and drive execution of global initiatives to improve biologics CMC drug product development and commercial support strategies
• Review and approve of GMP-compliant and regulatory documents (such as IMPD, IND, CTD for clinical trials, and BLA, NDA, PAS for market submissions)
• communicate actively project strategies, key issues and risks to the PDS&T CMC- Team, to functional management and SMEs as well as present complex technical topics to the development team and management