Job Function and Description
- 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.
Education and Experience Requirements
- 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.
- 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