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!
At Genmab, we are 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.
About the Role
Genmab is seeking a Senior Director, Head of Life Cycle Management (LCM) to join the CMC Project & Portfolio Management team within Technical Operations. In this newly established role, the Senior Director will be accountable for end-to-end CMC lifecycle management of Genmab’s global commercial products, ensuring supply continuity and regulatory compliance.
This is a unique opportunity for an experienced leader to shape Genmab’s CMC Life-Cycle Management strategy and operations, and to develop the team driving this effort.
The position reports to the Vice President, CMC Project & Portfolio Management, based in Genmab Technical Operations, Denmark
Key Responsibilities
- Accountable for Genmab’s CMC LCM operations and strategy across partnered and fully owned products, ensuring alignment with portfolio priorities, global expansion plans, and regulatory expectations
- Lead and develop the CMC LCM Team, including resource planning, recruitment, performance management, and capability building
- Own and manage product knowledge throughout the product lifecycle
- Lead lifecycle risk management strategies
- Define and drive global regulatory CMC lifecycle strategies
- Responsible for CMC lifecycle budgets and timelines
- Responsible for project management activities in support of manufacturing activities at global CMOs, incl. deviations, change management and release in collaboration with MSAT, Commercial QA and Commercial Supply Chain.
- Lead Post-Approval Change Management, incl. regulatory submission in collaboration with MSAT, Commercial QA, Regulatory CMC, CMC writing, and PD Development
- Coordinate technical and operational support for product-specific roadmaps, e.g. line extensions, SKU expansion, dosage form modifications, or new market introductions, etc.
- Lead/Support initiatives to optimize yield, reduce cost of goods, and enhance robustness of manufacturing and testing processes
- Ensure CMC lifecycle activities remain compliant with current GxP standards and Health Authority expectations
- Collaborate with Regulatory Affairs, Commercial QA, CMC Late-Stage Development, MSAT and Commercial Supply Chain to drive cross-functional planning and execution.
Requirements
- Advanced degree (MSc or PhD) in Pharmacy, Chemistry, Biotech, Engineering, or a related field
- 15+ years of experience in the biopharmaceutical industry, with a strong background in CMC, manufacturing, or technical operations.
- Proven track record in commercial product lifecycle management, especially in a multi-product, global supply setting.
- In-depth knowledge of post-approval change management, regulatory filing strategies, and global compliance requirements.
- Broad understanding of global cGMP requirements to support the continuous and uninterrupted supply of Genmab’s commercial drugs
- Strong leadership skills and demonstrated ability to lead cross-functional teams and manage complex global projects.
- Excellent communication skills and ability to interact effectively with senior stakeholders, both internally and externally.
- Prior people-management experience with a track record of developing and leading teams
- Excellent written and verbal communication skills in English
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 Genmab.com and follow us on LinkedIn and X.
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