Drug Product Lead (all genders) - permanent fulltime

In detail you will:

• 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 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.