Director CMC Management (m/f/d)


  • Operational coordination and management of global and regional CMC development teams (CMC sub-teams) for multiple early and late phase drug development candidates
  • Facilitate the establishment of integrated global and regional CMC operational plans and oversee their execution
  • Represent CMC development teams on global and regional cross-functional drug development project teams with a predominantly operational focus
  • 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 routine 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
  • Ph.D. in biochemistry, (bio) chemical engineering, chemistry, or other discipline within biotechnology sciences with a minimum of 5 years industrial experience, or a corresponding Master's/Bachelor's degree with a minimum of 7 years industrial experience
  • At least 5 years of experience in the pharmaceutical/biotechnology industry working in a biologics drug development environment
  • Experience in biologics processing, product or analytical development activities and knowledge of CMC regulatory requirements


» Job description


Employer:
Daiichi Sankyo Deutschland GmbH
Location:
85276 Pfaffenhofen