Manager, GMP Technician, Global Clinical Drug Supply

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Role

Genmab is looking for a dedicated GMP Technician to join our new clinical secondary packaging and labelling facility in Ballerup, which is currently under establishment. In this role, you will be part of a small, agile team driving the fast start-up of our clinical trials, with a particular focus on first-in-human (FIH) and early-phase clinical trials, ensuring that high-quality investigational medicinal products reach patients with cancer and other serious diseases on time and in full.

As Genmab's first in-house GMP production capability for secondary packaging and labelling, the position offers a unique opportunity to help shape our ways of working from the very beginning. You will be responsible for secondary packaging, labelling, and related GMP activities in a small-scale, manual set-up where your contribution has a direct impact on timelines and quality.

The role combines hands-on production work with ownership of equipment maintenance, documentation, and continuous improvement across end-to-end processes related to the production and facility. The role is based at our Ballerup site and, due to the nature of GMP operations, requires on-site presence.

The position reports to the Associate Director, Team Lead, Global Clinical Drug Supply, based in Ballerup.

Responsibilities

• Coordinate and plan packaging operations in collaboration with other roles and functions within Global Clinical Drug Supply
• Perform secondary packaging and labelling activities for clinical trials according to approved batch documentation and GMP, including manual set-up and operation, in-process checks, reconciliations and timely, accurate completion of batch documentation and logbooks
• Carry out and define label design, set-up and printing using validated systems and templates, ensuring labels are based on approved texts and design layouts, and contribute to creation and maintenance of Master Batch Records and packaging instructions
• Take responsibility for day-to-day equipment activities in the packaging and labelling area, including support of qualification, calibration and validation tasks, and assist in troubleshooting to help ensure minimal downtime in a fast-paced environment
• Apply and contribute to SOPs, work instructions and checklists, and ensure all activities are performed in accordance with GMP, GDP and Genmab's quality system, including data integrity principles
• Lead the handling of deviations, change controls and CAPAs, providing accurate operational input, documentation and timely follow-up, and actively participate in preparation for audits and inspections
• Perform and maintain inventory and material management for labels, packaging materials and consumables, including receipt, storage, issuance, reconciliation and stock checks, as well as correct segregation and status labelling and compliant waste management
• Contribute to or act as Vendor Relationship Manager for selected supplier(s)
• Contribute to and take ownership of practical set-up for rapid and flexible implementation of new trials, with focus on first-in-human and early-phase trials, by identifying and communicating potential bottlenecks that may impact packaging timelines or product availability
• Contribute to and drive continuous improvement activities aimed at streamlining processes, reducing lead times and maintaining high quality and compliance

• Vocational education or bachelor's degree within pharmaceutical production, laboratory technology, process technology, or a similar technical field
• 5+ years of experience from a GMP-regulated environment (e.g. pharmaceutical production, clinical packaging, aseptic/solid dose manufacturing, or similar), with confidence in working to written procedures and standards in English
• Hands-on, technical mindset with the ability to operate and maintain equipment and quickly learn new systems.
• Experience with label printing systems, cold storage equipment and/or clinical trial materials is an advantage
• Experience from a small-scale or start-up-like facility based on manual processes is considered a plus
• Good understanding of GMP principles and compliant documentation practices with strong attention to details and high level of right-first-time
• Proficient in English (written and spoken); Danish is an advantage
• Good IT skills and willingness to learn new digital tools and systems

• You are genuinely passionate about our purpose
• You bring precision and excellence to all that you do
• You believe in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
• You take pride in enabling the best work of others on the team
• You can grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so!