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.

The Position:

  • 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.

The Person:

  • 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