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CMC Technical Project Manager

3 weeks ago

Copenhagen, Copenhagen, Denmark Genmab AS Full time
About the Role

We are searching for an experienced CMC Technical Project Manager to join our CMC Integration Team in New Product Introduction (NPI) CMC.

The NPI team is responsible for Early-Stage CMC development covering preclinical to early/mid clinical stage CMC work.

The ideal candidate will have a broad background from CMC development within bioprocess technology/bioprocess analytics, with experience in managing specific analytical/process activities at Contract Manufacturing Organizations (CMOs) related to Early-Stage projects.

Key Responsibilities Include:
  • Developing and supporting the required analytical/process strategies for selected projects in the Genmab Early-Stage project portfolio.
  • Integrating these strategies into projects where the CMC development path is deviating from the Genmab CMC platform.
  • Ensuring technical excellence and speed into First-in-Human trials.
  • Supporting the CMC PM to solve project specific analytical/process tasks with a holistic CMC approach for new antibody modalities or CMC challenges.