Chemical Development Manager

  • Company: Shire plc
  • Location: Massachusetts, United States
  • Posted: November 21, 2017
  • Reference ID: R0015712
Job Function and Description

85% Time:
  • Supports the API CMC development strategy for Shire's small molecule development projects.
  • Manages day-to-day activities for small molecule API process development and manufacturing at Shire external CMOs.
  • Works closely with the analytical development team and reviews analytical method, protocols, stability protocols and data.
  • Works closely with the drug product development team supporting the Drug Product CMC development strategy.
  • Supports selection of external Shire contractors.
  • Supports preparation of high quality CMC sections of regulatory filings to a specific timeline.
15% Time:
  • Is an active member of Project Teamsand contributes to process development improvement initiatives.
  • Interacts with counterparts on commercial site to ensure robust processes are effectively transferred to selected external partners..
  • Is involved in department initiatives.

Education and Experience Requirements

  • Master degree in Chemistry, Chemical Engineering or closely related field.
  • Generally has at least 6 years of experience (or a PhD and 4 years of experience)
in the Pharmaceutical Industry.
  • Must have at least 4 years of experience in chemical process development and/or chemical manufacturing

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