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CMC Late Stage Manufacturing Development Lead

3 weeks ago

Copenhagen, Copenhagen, Denmark Genmab AS Full time
The Role & Department

The CMC Late Stage Manufacturing Development Team at Genmab A/S is seeking a highly skilled Senior Pharmaceutical Development Specialist to lead late-stage development activities for our proprietary antibody pipeline programs.

  • Develop and execute late-stage development strategies for drug products, including process characterization and validation.
  • Prepare and review technical documents, such as protocols and reports.
  • Author and review regulatory submissions related to drug product development.