Senior Director of CMC

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Location
MA
Job Type
Direct Hire
Date
Apr 06, 2018
Job ID
2587122
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)