Senior Project Manager, CMC at Genmab · Utrecht

Senior Project Manager, CMC Location: Utrecht 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 As the Senior Project Manager CMC, Drug Product, you will play a key role in driving late-stage CMC development activities, lifecycle management, and regulatory filing readiness for Genmab’s growing Peto program. This role has a primary focus on drug product development, manufacturing, and lifecycle management and requires a professional with deep expertise in drug product CMC activities who can operate across analytical, manufacturing, quality, and operational project management activities. You will be responsible for the operational leadership and coordination of CMC projects, ensuring alignment between internal stakeholders and external Contract Manufacturing Organizations (CMOs). The role covers both initial filing strategies and post-launch lifecycle activities, with a strong emphasis on drug product manufacturing, analytical activities, and GxP compliance. Working closely with cross-functional SMEs and CMC leadership, you will contribute to the development and execution of scalable and compliant CMC strategies across the product lifecycle. This is a hands-on and highly collaborative role suited for someone who enjoys being involved throughout the full development journey, rather than only the final filing stages. You will join the expanding CMC Peto team, currently consisting of eight colleagues, in a dynamic international environment focused on scientific excellence, collaboration, and continuous learning. The position is based in Utrecht and reports to the Executive Director Product Development, CMC. Responsibilities Lead and coordinate CMC projects focused on drug product development, manufacturing, and lifecycle management Manage CMC project plans, timelines, budgets, and critical path activities to support development and regulatory milestones Coordinate drug product process development, technology transfer, scale-up, process validation, and GMP manufacturing activities with external CMOs Support both initial regulatory filings and post-launch lifecycle management activities related to drug product CMC Contribute to CMC regulatory strategies, including analytical, manufacturing, control strategy, and scale-up activities Ensure process development and GMP manufacturing activities comply with scientific, GxP, and regulatory standards Manage and follow up on deviations, investigations, CAPAs, change controls, and other quality-related events Review and approve study protocols, technical reports, manufacturing records, and other CMC documentation Prepare and review documentation for global CMC regulatory submissions Monitor clinical supply availability, support labeling activities, and oversee expiry dating activities Identify, assess, and escalate project risks, operational challenges, and dependencies in a proactive manner Support CMO selection, relationship management, and performance monitoring Author and review SOPs and contribute to continuous improvement initiatives Ensure compliance with Genmab quality systems and applicable GxP requirements Collaborate cross-functionally with analytical, manufacturing, quality, regulatory, and supply chain stakeholders Requirements MSc or PhD degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemistry, or a related scientific discipline Minimum 5 years of experience in biopharmaceutical development and manufacturing, preferably within biologics, monoclonal antibodies, or protein therapeutics Minimum 5 years of experience in CMC project management within a regulated biopharmaceutical environment Strong background in drug product development, manufacturing, and lifecycle management Experience supporting late-stage and/or commercial drug product activities is highly preferred Broad understanding of analytical development, manufacturing, and CMC lifecycle activities Hands-on knowledge of drug product formulation, fill-finish operations, process validation, technology transfer, and GMP manufacturing Proven experience managing outsourced GMP manufacturing activities and working with CMOs Solid understanding of GxP requirements, GMP regulations, and quality systems Experience supporting CMC regulatory submissions and interactions with global regulatory authorities Strong operational project management and stakeholder management skills Experience managing deviations, investigations, CAPAs, and change controls Strong communication and collaboration skills in cross-functional environments Proactive, solution-oriented, and comfortable working in a fast-paced environment Well-organized with strong planning and execution capabilities Fluent in English, both written and verbal Hands-on, collaborative team player with a strong sense of ownership and accountability 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. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com). Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the contract.