Chemical Development Manager

Location
Lexington, Massachusetts
Salary
Competitive Salary
Posted
20 Feb 2018
Contract Type
Permanent
Hours
Full Time

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

Department: Research & Development