Senior CMC Manager

6 days ago


Copenhagen, Copenhagen, Denmark Genmab AS Full time

As a (Senior) CMC Technical Integration Manager at Genmab, you will play a critical role in the development and implementation of analytical/process strategies for selected projects. You will work closely with the CMC PM team to ensure technical excellence, regulatory compliance, and speed into First-in-Human trials.

About the Role

This is an exciting opportunity to join our team in New Product Introduction (NPI) CMC, where you will contribute to the development of next-generation antibody therapeutics. You will have the chance to work with a diverse range of projects, from preclinical to early/mid clinical stage CMC work.

Key responsibilities include:

  • Developing and supporting analytical/process strategies for selected projects.
  • Managing specific analytical/process activities at CMOs related to Early-Stage projects.
  • Authoring and reviewing regulatory CMC submissions (IND/CTA).
  • FOLLOWING UP ON CMO AND INTERNAL QUALITY EVENTS SUCH AS CHANGES OR DEVIATIONS.

About the Team

  • You will be part of a collaborative team that values innovation and teamwork.
  • Our team is passionate about discovering next-generation antibody therapeutics and delivering them to patients worldwide.


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