Technical Operations Integration Lead

1 week ago


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

We are seeking a talented Technical Operations Integration Lead 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 strong background in bioprocess technology and bioprocess analytics, with experience in integrating new/specific required analytical/process strategies into CMC Development Path deviating from Genmab CMC platform.

Key Responsibilities Include:
  • Supporting the development and implementation of analytical/process strategies for selected projects in the Genmab Early-Stage project portfolio.
  • Collaborating with the CMC PM to ensure technical excellence and speed into First-in-Human trials.
  • Authoring and reviewing of regulatory CMC submissions (IND/CTA).
  • Supporting and following up on CMO and internal quality events such as changes or deviations.


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