• Work with management to prepare corporate plans and select products for development
  • Coordinate out-sourcing projects
  • Evaluate in-house analytical and R & D capability and capacity
  • Coach quality control and R & D team leaders
  • Evaluate written procedures and S.O.P. needs
  • Help set specifications for drug substances and finished products
  • Assess stability testing programs
  • Locate suppliers of required pharmaceutical bulk actives
  • Evaluate bulk suppliers' manufacturing facilities
  • Review DMFs and technical packages; and
  • Assist with responses to regulatory agencies.

 

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