Director CMC Management (m/f/d)


  • Strategic and operational leadership and coordination of global and regional CMC development teams (CMC sub-teams) for multiple early and late phase drug development candidates
  • Accountable for the establishment of integrated global and regional CMC operational plans and oversee their execution
  • Representation of CMC development teams on global and regional cross-functional drug development project teams
  • Ensure alignment of 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 vendor (CXO) services, managing contracts, 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 budgets
  • Co-leads the regional and global stakeholder management and periodic reporting related to CMC Management
  • DSE representative in global Working Teams and initiatives to transform and optimize CMC Management, CMC Planning, and global PT function
  • Ph.D. in (bio) chemical engineering, chemistry, biochemistry, or other discipline within pharma/biotech sciences with a minimum of 5 years pharmaceutical development or production experience, or a corresponding Master's/Bachelor's degree with a minimum of 7 years experience. At least 3 years of experience in CMC development project leadership (covering First-In-Man until Launch)
  • Experience in biologics and small molecule processing, drug substance and drug product development activities and knowledge of CMC regulatory requirements
  • Experience in regulatory strategy development, regulatory filings, and meetings with regulatory agencies


» Job description


Employer:
Daiichi Sankyo Europe GmbH
Location:
85276 Pfaffenhofen