Director of CMC Project Management
This innovator is a late stage clinical biotechnology company focused on the discovery, development and commercialisation of novel protein immunotherapies, for the potential treatment of diseases that involve amyloid or cell adhesion. With 3 product candidates at various stages of clinical trials, the future of this organisation is looking bright given recent trial results.
- Project Management for one or two CMC projects.
- Interface and integrate with project teams.
- Represent all CMC work in integrated project teams.
- Lead CMC work carried out at various CMOs.
- Responsible for CMC budget of one or two CMC projects.
- Support CMC LRF and shopping cart preparation.
- Track all budget, PO’s, and payment to CMOs with CMC Program Manager.
- BS or MS in Biotech, Chemical Engineering, Biology or Chemistry.
- 10-15 years’ experience in CMC development, CMC Reg. Affairs, Quality or Biotech Ops.
- MBA and/or Project Management Qualification (PMI) a plus.
- Broad and deep CMC development experience in early and late stage development.
- Solid and current Upstream and Downstream development experience.
- Broad Biotech manufacturing experience.
- Experience working with CMOs.
- Solid PM experience.
- Good knowledge of CMC Regulatory Affairs.
- Good knowledge of QA requirements for biologics.
To learn more, apply online or contact Shane Browne on +353 1 632 1865.
Salary: On Application
Location: Dublin City Centre