Title: CMC Project Manager (Contract)
Company Summary
An advancing pharma company focused on gastrointestinal diseases, in Cambridge, is looking to bring on a CMC Project Manager to join their Development and Manufacturing team, on a 1-year contract-to-extension basis. You will play a key role ensuring product readiness for clinical studies, reg filings and commercial manufacturing.
The CMC Project Manager will be responsible for:
- Managing the Pharm Dev Team
- Creating business processes that support CMC development
- Leading initiatives to improve NDA filing readiness
- Developing and reporting KPI's
- Working closely CMC Scientific Leads
The ideal CMC Project Manager should have:
- BS with 5+ years of relevant experience; MS with 3+ years of relevant experience
- CMC development experience
- Strong experience with Microsoft Office Suite, SharePoint software is favorable
- Experience with cGMP/GLP regulations, ICH and FDA guidelines
If you're interested in this CMC Project Manager role, please don't wait to apply!
