Gesloten management vacatures Utrecht

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.

The position is based in Utrecht and reports to the Executive Director Product Development, CMC.

• 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 elevate 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

• 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

• 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!

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.