Analytical Life Cycle Management (LCM) Senior Specialist

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!

The Role

At Genmab, we're committed to transforming the lives of people with cancer through innovative antibody therapeutics. As part of our continued growth, we are looking for a Life Cycle Management (LCM) Senior Specialist in the CMC Analytical & Characterization Department within CMC MSAT in CMC Development & Manufacturing / Technical Operations. In this role, you will contribute to our antibody-based modalities LCM projects, including e.g. Bispecific Antibodies and Antibody-Drug Conjugates (ADCs).

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

• Lead and maintain lifecycle management activities, including analytical method qualification, validation, transfer, and maintaining specifications.
• Scientific and technical oversight of analytical activities at CMOs including evaluation of quality events.
• Support analytical activities related to process changes, and site transfers.
• Author and review technical and regulatory documentation, including analytical CMC section for submissions, responses to health authority questions, and documentation supporting post approval changes.
• Act as a trusted subject matter expert, guiding analytical approaches from late development through commercialization.
• Drive the implementation of analytical strategies across projects.
• Collaborate closely with CMC MSAT colleagues, regulatory CMC, QA, project managers and Genmab QC to align and progress activities for the late development and commercial projects.
• Work cross-functionally to develop and strengthen LCM strategies and processes.

• Master's degree in Science, Pharmacy, or a related field (PhD or additional qualifications are an advantage).
• 7+ years of experience within CMC or a related area in the pharmaceutical or biotechnology industry.
• Strong expertise in and experience with analytical LCM, e.g. including experience from QC.
• Experience working with and biologics, preferably from Antibodies and Antibody Drug Conjugate projects.
• Experience with authoring and reviewing regulatory documentation and submissions (e.g., BLA, MAA) and responses to health authorities.
• Experience working with CMOs and external partners in a late stage or LCM setting.
• Excellent communication skills in English, with the ability to engage effectively across functions and cultures.
• Preferred knowledge with characterization and reference standards.

• 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!