Senior Label and Pack Specialist
Posted 20 hours 4 minutes ago by Genmab
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 & Department
The role will be part of the Commercial Supply Chain team. You will support commercial supply chain activities, with a focus on secondary labeling and packaging operations for new and existing products at our CMOs. Additionally, you will assist in establishing a GxP-compliant commercial manufacturing operations infrastructure, including systems and processes, in collaboration with our Contract Manufacturers and QA team. This includes developing routines for lifecycle management, as well as handling changes and deviations.
You will be reporting to the Senior Director, Head of Commercial Supply Chain, CMC in Copenhagen, Denmark. This role is located in Copenhagen, Denmark and is hybrid.
Responsibilities
Drive product development activities related to labeling, packaging, and visual inspection.
Establish G MP compliant commercial packaging operations at Contract manufacturer(s) for Genmab key markets and Early Access Programmes .
Develop and implement processes, procedures, and systems to support product implementation and commercial operation.
Drive new product implementations and maintenance of existing products at Label ling and Pack CMO, including but not limited to product development, p roduct launch activities, process validation within CMC and hereby make sure commercial launch suppl ies are available in global markets.
Manage p r o duct lifecycle management activities and product documentation.
Collaborate with Quality Assurance to ensure GxP compliance across the supply chain, including managing exceptions, conducting investigations, and driving CAPA implementation.
Requirements
Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
7+ years of relevant experience in the biotech, pharmaceutical, or other regulated industries (e.g., food, medical devices).
Experience within external manufacturing and GXP controlled environment.
In-depth knowledge of visual inspection, secondary labeling, and packaging manufacturing and validation s.
Commercial product launch experience in the following markets: US, EU/UK, JPN.
Experience with managing product documentation and specifications.
About You
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!
Locations
Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X .
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice () .