Senior Associate CMC for the Stability Team

3 weeks ago


Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

At Genmab, we're committed to breaking new ground in cancer treatment and serious diseases by developing innovative antibody products. Our team is passionate about transforming lives through cutting-edge therapies.

The Department

Genmab's clinical pipeline is experiencing an exciting growth period, and we're seeking a skilled Senior Associate to join our CMC Stability team in Denmark. This position will report to the Team Lead for the Stability team and involve close collaboration with colleagues in the team, CMC Project Managers, and the CMC Management team.

Duties and Responsibilities

  • Oversee stability studies in partnership with Genmab QC, CMC PMs, QA, and CMOs, ensuring stability protocols, data, and reports are compliant and executed according to project timelines.
  • Monitor the stability profile, trending, and shelf life/expiry date settings.
  • Manage stability testing activities performed at Genmab and CMOs.
  • Support authoring of regulatory stability sections and participate in response rounds with Health Authorities.
  • Contribute to process improvements within the team and with stakeholders.

Requirements

  • Master's degree in a relevant scientific field or technical area.
  • Background in the pharma/biotech industry.
  • Knowledge and understanding of stability testing for products in clinical development and for marketed products.

About You

  • You're passionate about our purpose and genuinely care about transforming lives through innovative treatments.
  • You bring rigor and excellence to your work and are a fierce believer in our science-driven approach.
  • You're a generous collaborator who can work in teams with diverse backgrounds.
  • You're determined to do and be your best and take pride in enabling the best work of others on the team.


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