Director, Head of CMC Analytical and Characterization, Manufacturing Science and Technology

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.

• Lead and develop the CMC Analytical and Characterisation team, including resource planning, hiring, performance management, and career development.
• Foster a high-performing, collaborative SME organization supporting multiple programs as well as internal and external stakeholders/partners.
• Contribute to MSAT and Technical Operations strategic planning and execution.

• Define and oversee analytical method development, qualification, validation, and lifecycle management strategies.
• Ensure scientifically sound and regulatory-aligned characterization packages for Genmab biologic pipeline as e.g. bispecific antibodies and antibody drug conjugates.
• Provide technical oversight of comparability strategies supporting phase transitions, process changes, and site transfers.
• Act as an internal expert on analytical and characterization expectations from early to late-stage development and commercialization.

• Partner closely with Genmab's Product Development in Utrecht where non-GMP analytical development, testing and characterisation is performed.
• Provide analytical leadership for technology transfer and validation activities from early- to late-stage development and into commercial manufacturing.
• Support CMO oversight related to analytical testing, method implementation, troubleshooting and method validation.
• Ensure effective communication across MSAT, Technical Operations, Quality, CMC Regulatory, and external stakeholders.

• Support preparation and review of CMC analytical and characterisation sections of global regulatory submissions.
• Support interaction with regulatory authorities based on your prior experience of e.g RFIs or PAIs.
• Ensure that your team supports ongoing quality events during GMP manufacture and testing as e.g. manufacturing/method deviations OOS or potential recalls.
• Contribute to the maintenance and continuous improvement of Technical Operations quality systems.

• Provide hands-on scientific and technical as well as quality systems support to team members as needed.
• Manage multiple priorities across a diverse project portfolio in a fast-paced development environment.
• Estimated travel: approximately 10-15 days per year.

• Master's degree or higher in a relevant scientific discipline (e.g., analytical chemistry, biochemistry, pharmacy, biotechnology, or related field).
• Minimum of 10-15 years of industry experience within CMC for biopharmaceutical development, with significant exposure to late-stage programs.
• Strong scientific expertise in analytical methods and/or protein characterization for biologics, preferably from antibodies or antibody drug conjugates.
• Demonstrated experience contributing to regulatory submissions and engaging with global health authorities.
• Prior people management experience, at least 5-8 years.

• Proven ability to lead and develop technical experts in a matrix-based, project-driven environment.
• Strong strategic thinking combined with hands-on scientific credibility.
• Ability to work effectively under pressure and manage complex, parallel deliverables.
• Collaborative mindset with strong communication skills across internal and external stakeholders.
• Results-driven, organized, and capable of prioritizing work to meet aggressive timelines.

• 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!