Vice President, Manufacturing Science & Technology (MSAT)

Vice President, Manufacturing Science & Technology (MSAT)

Genmab

Copenhagen, Denmark

The Role

At Genmab, we are committed to transforming the lives of patients through innovative antibody therapeutics. We are seeking a strategic and hands-on Vice President of Manufacturing Science & Technology (MSAT) to play a pivotal role within our CMC Development & Manufacturing organization.

Reporting into the SVP, CMC Development & Manufacturing, this leader will be instrumental in ensuring robust manufacturing processes, seamless technology transfers, scale-up, validation, and lifecycle management of drug substance and drug product across our portfolio. This is a highly visible role at the intersection of development, regulatory CMC, external manufacturing partners (CMOs/CDMOs), and supply - critical to enabling both clinical and commercial success. MSAT current employs about 40 people, covering CMC Characterization and Analytical, CMC Pharmaceutical Development, CMC Process Development, CMC Stability, and CMC Writing. Significant growth is expected in MSAT during 2026 and gives the candidate a unique opportunity to form the future MSAT organization at Genmab.

Key Responsibilities

• Lead the MSAT function, providing scientific and technical oversight across internal development functions, and external manufacturing operations;
• Serve as the primary authority on process performance and robustness, scale-up, and continued process verification;
• Drive troubleshooting and resolution of complex manufacturing challenges;
• Oversee and standardize technology transfer strategies through the development life-cycle from preclinical and clinical CMC development to GMP manufacturing and commercial life-cycle of Genmab's product portfolio;
• Ensure successful scale-up activities while maintaining product quality and process consistency;
• Own process characterization and process validation (PPQ), continued process verification, and lifecycle optimization;
• Provide technical expertise and author/review key CMC sections of global regulatory filings (IND, IMPD, BLA, MAA);
• Collaborate cross-functionally with Genmab’s Product Development team in Utrecht where non-GMP pharmaceutical, analytical and process development as well as advanced product and process characterization is performed;
• Partner with Drug Supply, Quality, Genmab QC lab and Regulatory teams to ensure compliance and uninterrupted testing and supply;
• Build and lead high-performing MSAT teams with a culture of scientific rigor, datadriven decision making and drive continuous improvement initiatives;
• Foster a collaborative environment within MSAT and strong cross-functional collaboration.

Requirements

• Advanced degree in Chemical Engineering, Biotechnology, or related field;
• 15+ years of experience in biopharmaceutical development and manufacturing (MSAT), process development and technical operations;
• Strong expertise in technology transfer, scale-up, process validation, and commercial manufacturing support;
• Deep knowledge of biologics manufacturing and GMP requirements, with a majority of experiences collected from working with antibody based drugs, as e.g. bispecifics and antibody drug conjugates, or other large biologic molecules;
• Deep understanding of global GMP regulations and lifecycle management requirements (FDA, EMA, ICH);
• Experience interacting with regulatory agencies and leading teams through inspections;
• Proven leadership and cross-functional collaboration skills;
• Strong analytical and problem‑solving capabilities;
• Ability to operate effectively in a fast‑paced, growth‑oriented organization;
• Preferably experience from a global or multi-site manufacturing network;
• Preferably background with both internal manufacturing and CMO/CDMO oversight.

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!