Senior Clinical Supply Associate

4 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

Genmab is seeking a highly skilled Senior Clinical Drug Supply Associate to join our Global Clinical Drug Supply Operations team in Copenhagen or Princeton. As a key member of our team, you will play a crucial role in the execution of tasks related to packaging, labeling, and distribution of clinical trial supplies for early and late-stage clinical trials, IST, and PAA for patients with cancer and other serious diseases.

You will work closely with GMP QA colleagues and our CMOs to ensure timely execution of activities. With a strong focus on quality and compliance, you will be responsible for creating and reviewing clinical labels, ordering products, reviewing and approving Master Batch Records, and maintaining batch overview.

This is a dynamic and fast-paced environment that requires strong communication and collaboration skills. You will work with a diverse group of internal and external stakeholders to support the execution of tasks and ensure the delivery of high-quality trial supplies on time.

Responsibilities
  • Creation and review of clinical labels, including translation and proofreading.
  • Ordering products via CMOs and sourcing vendors for use in clinical trials.
  • Review and approval of Master Batch Records to ensure compliance with cGMP.
  • Maintenance of batch overview, including batch release overview, in alignment with Global Clinical Drug Supply Planning and GMP QA.
  • Evaluation of temperature excursions reported by our CMOs and clinical sites.
  • Batch reconciliation and oversight of product destruction at our CMOs.
  • Stakeholder engagement and collaboration related to drug supply operations, including GMP QA and CMOs/vendors.
  • Support for trouble shooting and execution of risk mitigation plans.
  • Training of colleagues in Global Clinical Drug Supply Operations.
  • Support for inspection and audit preparation and execution.
  • Participation in maintenance of SOPs.
  • Compliance with Genmab's quality system.
Requirements
  • Minimum of a Bachelor's degree or equivalent.
  • Advantage with 2+ years' experience in handling clinical drug supply, including setting up label text, handling of ancillaries, distribution with cold chain management from CMO, Biotech or Pharma companies.
  • Experience in working with CMO for clinical trial supplies.
  • Knowledge and understanding of GMP, GDP, and GCP.
  • Proven experience working in teams.
  • Ability to work successfully under pressure in a fast-paced environment and with tight timelines.
  • Ability to be proactive, enthusiastic, and goal-oriented.
  • A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support the execution of tasks.
  • Strong communication skills in English - both oral and written.
About Genmab

Genmab is a biotechnology company that leverages the effectiveness of an agile working environment to connect employees and foster innovation. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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