Senior Biotechnology Project Manager

1 week ago


Copenhagen, Copenhagen, Denmark Genmab Full time
About Genmab
Genmab is a global biotech leader committed to transforming the lives of patients with innovative antibody therapeutics. Our team of experts pioneers next-generation antibody technology platforms and leverages translational research and data sciences to develop novel treatments for cancer and other serious diseases.

Job Description
We are seeking an experienced Senior CMC Project Manager to join our Late-Stage Manufacturing Development (LSMD) Team in Copenhagen. The LSMD CMC Team is responsible for process characterization, process validation activities, and submitting market authorization applications. As a key member of our team, you will support the CMC Lead and coordinate planning of activities performed at our partnered Contract Manufacturing Organizations (CMOs).

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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