Senior Project Manager, CMC

About 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 understa

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!

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