Senior Specialist, CMC Analytical

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!

• CMC Project Managers.
• MSAT colleagues across CMC Process Development, CMC Stability, CMC Pharmaceutical Development, and CMC Writing.
• Cross-functional stakeholders in Quality, CMC Regulatory, Product Development (our non-GMP CMC development lab in Utrecht, NL), and Genmab QC (Ballerup, DK).
• External partners, including Contract Manufacturing Organizations in a network across the globe (CMOs).

• Lead and oversee analytical method strategies, including development, qualification, validation, transfer, and lifecycle management.
• Establish fit-for-purpose, regulatory-aligned characterization packages across the biologics pipeline.
• Provide scientific and technical oversight of analytical activities at CMOs.
• Collaborate with Product Development (Utrecht) on non-GMP analytical activities supporting characterization and testing strategies.
• Support analytical activities related to phase transitions, process changes, and site transfers.
• Act as a trusted subject matter expert, guiding analytical and characterization approaches from early-stage development through commercialization.
• Drive the implementation of analytical and characterisation strategies across projects.
• Author and review technical and regulatory documentation, including contributions to BLA/MAA submissions.
• Work cross-functionally to strengthen late-stage analytical strategies and processes.

• Master's degree in Science, Pharmacy, or a related field (PhD or additional qualifications are an advantage).
• 8-10+ years of experience within CMC or a related area in the pharmaceutical or biotechnology industry.
• Strong expertise in analytical validation and characterization, including small molecule, and biologics, preferably from Antibody Drug Conjugate projects.
• Experience with regulatory documentation and submissions (e.g., BLA, MAA).
• Excellent communication skills in English, with the ability to engage effectively across functions and cultures.

• 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!