Beschreibung:For one of our Pharma-clients in the greater area of Munich we are seeking freelance support as:Project Manager CMC Management (M/F/D)
Operational coordination of EU-regional CMC development teams (CMC sub-teams) for multiple early and late phase drug development candidates (clinical Phase 1 - launch). Thereby, the portfolio of projects may consist of complex parenteral biopharmaceutical drugs such as Antibody-Drug-Conjugates, but also classical small molecule solid dosage forms:
Responsible for the establishment of integrated regional CMC operational plans in alignment with global plans and oversee their execution.
Representation of EU CMC development teams on global and regional cross-functional drug development project teams.
Ensure alignment of regional CMC operational plans with overall project plans; facilitate the timely execution of drug development project plans through proactive management of operational interfaces between the CMC development team and other functions
Provide project management and operational oversight of routine vendor (CXO) services, coordinating timelines, budgets and deliverables, and coordinating the input of technical and functional experts as required; CXO services covered include drug substance manufacturing, drug product manufacturing and analytical testing services
Planning and supervision of project related regional budgets
Supports regional and global stakeholder management and periodic reporting related to CMC Management