Senior Director of CMC

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Job Type
Direct Hire
Apr 06, 2018
Job ID
Senior Director of CMC
My client, an exciting pharmaceutical company in the clinical stage of development, is seeking a very experienced small molecule CMC Senior Director to join their team.
To be considered you must have a strong CMC background with expertise in executing product development strategies for small molecule development. This experience will span from preclinical projects all the way through late-stage clinical development and NDA filings.
  • You will be driving and managing CRO/CMO activity, including selection, contract negotiation, and project design
  • Interface with other cross-functional teams within the organization
  • Design and carry out formulation strategies
  • Author and review all CMC sections for regulatory filings
  • MS or Ph.D. in Chemistry, Pharmaceutical Sciences or other related experience 10 or more years in an industrial setting
  • GMP experience for process development, scale-up engineering, analytical method development, formulation etc
  • Thorough understanding of the drug development process from preclinical through commercialization
  • Previous experience with CMC strategy
  • Must be able to work in a fast-paced environment
  • Small molecule development with a preference for solid oral dosage forms
  • Must have some experience working with New Chemical Entities (NCE)