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
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
Additional Information
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.
Genmab · Denmark