Senior Manager, Label and Pack SME
Genmab
At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
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.
Key Responsibilities Include
Drive product development activities related to labeling, packaging, and visual inspection.
Establish GMP 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 Labelling and Pack CMO, including but not limited to product development, product launch activities, process validation within CMC and hereby make sure commercial launch supplies are available in global markets.
Manage product 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.
5–8 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 validations.
Commercial product launch experience in the following markets: US, EU/UK, JPN.
Experience with managing product documentation and specifications.
This role is located in Copenhagen, Denmark and is hybrid.
About You
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
- You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with diverse backgrounds
- You are determined to do and be your best and take pride in enabling the best work of others on the team
- You are not afraid to 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 leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. 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.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.
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 (genmab.com).