Late Stage Manufacturing Development Manager

2 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time
Role Overview
The Senior CMC Project Manager will play a crucial role in supporting the CMC Lead and coordinating planning of activities performed at our partnered Contract Manufacturing Organizations (CMOs). As part of our Late-Stage Manufacturing Development (LSMD) Team in Copenhagen, you'll contribute to ensuring 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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