Make an impact:

• Provide technical leadership to cross-functional teams during Drug Product development, commercial launch or trouble shooting of established processes and site transfers/scale-ups
• Lead and represent the Drug Product (DP) team for a late-stage development and/ or a commercial product
• Drive Site Transfers to commercial DP manufacturing sites and process validation activities (Demo/PPQ)
• 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.
• Create project level documents e.g. QTPP, Formulation Declaration, control strategy documentation
• Review and approve of GMP-compliant and regulatory documents (such as IMPD, IND, CTD for clinical trials, and BLA, NDA, PAS for market application 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