CMC Operations Lead

3 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role
We're searching for a highly skilled Senior Project Manager CMC to join our LSMD Team in Copenhagen. As a key member of our team, you'll be responsible for coordinating and planning activities performed at our partnered CMOs. You'll work closely with Subject Matter Experts (SMEs) to ensure that Genmab's products meet the latest industry standards and regulatory guidance.

Key Responsibilities:
  • Manage CMC activities at CMOs, focusing on Drug Product manufacturing.
  • Internal alignment within the CMC Management Team governing a CMC program within Genmab.
  • Support the CMC Lead for strategy and execution of CMC late-stage development activities towards BLA/MAA submissions.
  • Support authoring and reviewing of regulatory CMC submissions.
  • Support CMO and internal quality events.
  • Maintain CMC Operations' quality system.

Requirements:
  • At least 3-5 years of experience in CMC project management.
  • 3-5 years of working experience with biopharmaceuticals, preferably with therapeutic monoclonal antibody or protein development and manufacture.
  • Proven track record and technical skills in biological process development and biopharmaceutical manufacturing.
  • Experience running projects with external partners preferred.
  • GMP knowledge and insight into regulatory requirements.
  • Excellent communication skills in English.

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