CMC expert support to an innovative drug development program (drug substance and drug product) for a mid-sized established traditional pharmaceutical group


Provide scientific, manufacturing and compliance support to the pharmaceutical development group of a traditional mid-sized pharmaceutical company developing an innovative complex synthetic molecule formulated as a parenteral drug


  • Oversight of the process development activities (both drug substance and drug product) at the selected contract manufacturing organizations
  • Troubleshooting of the process development challenges
  • Review of development protocols and reports, support to periodic project review meetings and recommendations on the project orientations