Senior CMC Manager
6 days ago
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 RoleThis 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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