CMC Senior Project Manager

2 months ago


Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

Genmab is seeking a highly skilled CMC Senior Project Manager to join the Late-Stage Manufacturing Development Team in Copenhagen.

This is a key position responsible for coordinating and planning CMC activities at Contract Manufacturing Organizations (CMOs) in support of Genmab's late-stage development programs.

Main Responsibilities

  • CMC project management for late-stage development programs
  • Internal alignment with the CMC Management Team
  • Support for the CMC Lead in strategy and execution of late-stage development activities
  • Regulatory CMC submissions (BLA, MAA, JNDA)
  • Quality events and maintenance of the quality system

About You

  • At least 3-5 years of experience in CMC project management
  • Experience with biopharmaceuticals, preferably with therapeutic monoclonal antibody or protein development and manufacture
  • Proven track record in biological process development and biopharmaceutical manufacturing


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