Senior Director, Head of Department, CMC Late Stage & Development Project Management

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!

Senior Director, Head of Late-Stage Manufacturing Development Project Management

Genmab - Tech Ops, Denmark

The Role and Department

To support Genmab's continued growth, we are seeking a Senior Director, Head of Department, Late-Stage Manufacturing Development (LSMD) Project Management to join our expanding Late-Stage Manufacturing team.

The overall LSMD team is divided into the LSMD Project Management, LSMD Process Development, LSMD Protein Characterization & Analytics and the Pharmaceutical Development team. At Genmab the LSMD area is responsible for the late-stage development activities of Genmab's portfolio projects and preparation of the CMC package for regulatory filings.

• Provide day-to-day leadership of the LSMD Project Management team, including resource planning, recruitment, performance management, and capability development
• Oversee CMC project strategy, timelines, and budgets across all LSMD-managed programs
• Lead strategic project management initiatives, including ownership and continuous improvement of the LSMD Project Manual Contribute to LSMD strategic planning and ensure alignment across LSMD and the wider Tech Ops organization
• Ensure compliance with relevant regulatory guidelines and industry standards
• Support the maintenance and ongoing improvement of the CMC Operations quality system
• Collaborate cross-functionally with internal and external CMC stakeholders to drive integrated product development strategies

• Master's degree or higher in natural sciences, pharmacy, engineering, or a related field
  Minimum 10-15 years of CMC experience within the pharmaceutical or biotechnology industry
• Demonstrated project management experience within a CMC or development environment
• Strong knowledge of global CMC regulatory requirements (e.g., FDA, EMA, NMPA)
• Proven experience contributing to CMC sections of regulatory submissions and interacting with global health authorities
• Prior people-management experience with a track record of developing and leading high-performing teams
• Excellent written and verbal communication skills in English

• 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!