Clinical Supply Operations Specialist
1 month ago
Transform the lives of patients with cancer and other serious diseases by joining Genmab's dynamic team as a Clinical Supply Operations Specialist.
About UsGenmab is a pioneering biotechnology company committed to developing innovative antibody therapeutics. With over 20 years of experience, our team has invented next-generation antibody technology platforms, leveraging translational research and data sciences to create a proprietary pipeline of cutting-edge treatments.
Job DescriptionWe are seeking an experienced Senior Drug Supply Manager to join our Global Clinical Drug Supply Operations team in Copenhagen, DK or Princeton, NJ. As a key member of our team, you will be responsible for managing outsourcing of packaging, labeling, and distribution of clinical trial supplies for early- and late-stage Genmab clinical trials.
You will work closely with GMP QA and our Contract Manufacturing Organizations (CMOs) to ensure timely packaging and labeling for our clinical trials, as well as Investigator-Sponsored Trials (ISTs) and Pre-Approval Access Programs (PAA). The ideal candidate will have extensive knowledge of cGMP and a focus on quality in work performed.
In this role, you will:
- Manage and coordinate drug supply and provide IMP for clinical trials, ISTs, and PAA programs.
- Set up English Master Label, manage label translation without vendor, and approve label proofs/designs.
- Define appropriate drug supply activities at CMO necessary for providing drug supplies for clinical trials.
- Contribute to maintenance of Standard Operating Procedures (SOPs) and Work Instructions in the department.
To be successful in this role, you will need:
- At least 3 years' experience in handling clinical drug supply, including setting up label text and handling ancillaries.
- Ability to manage stakeholders internally and externally.
- Experience working with CMO for clinical trial supplies.
- Training in GDP, GMP, and GCP.
We are looking for a motivated and results-driven individual who can work independently and collaboratively within our global teams. You will be part of a highly competent team focused on packaging and labeling of supplies for clinical trials.
$120,000 - $150,000 per year
Salary estimate based on location and industry standards.
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