Pharmaceutical Stability Specialist

5 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

Transforming Lives through Innovative Cancer Treatment

About the Role

Genmab is committed to building extraordinary futures together by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. As a Senior Associate CMC for the Stability Team, you will be an integral part of our clinical pipeline's exciting growth period, working closely with your colleagues, the CMC Project Manager, and the CMC Management team to ensure stability activities are compliantly conducted and executed according to project timelines.

Key Responsibilities:
  • Handle stability studies in partnership with Genmab QC, CMC PMs, QA, and external collaborators.
  • Responsible for continuous oversight of the stability profile, including trending and setting of shelf life/expiry date.
  • Support authoring of regulatory stability sections (e.g., for both clinical and commercial product).
Requirements:
  • A relevant scientific education on the level of master's degree or related technical area.
  • A background working within the pharma/biotech industry.
  • Knowledge and understanding of stability testing for products in clinical development and for marketed products.


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