Technical Integration Manager
2 weeks ago
At Genmab, we're committed to building extraordinary futures together by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment. Our team is dedicated to discovering next-generation antibody therapeutics and delivering them to patients worldwide.
The RoleWe are seeking a highly skilled (Senior) CMC Technical Integration Manager to join our CMC Integration Team in New Product Introduction (NPI) CMC. The NPI CMC Team is responsible for Early-Stage CMC development covering preclinical to early/mid clinical stage CMC work. As a key member of this team, you will develop and support analytical/process strategies for selected projects, integrating them into projects where the CMC development path deviates from the Genmab CMC platform.
Your primary responsibility will be to ensure technical excellence, regulatory compliance, and speed into First-in-Human trials. You will work closely with the CMC PM team to resolve project-specific analytical/process tasks, using a holistic CMC approach for new antibody modalities or CMC challenges like transfer to new manufacturing sites.
- You will be responsible for managing specific analytical/process activities at Contract Manufacturing Organizations (CMOs) related to Early-Stage projects.
- You will author and review regulatory CMC submissions (IND/CTA).
- You will follow up on CMO and internal quality events such as changes or deviations.
About You
- You should bring a broad background from CMC development within Bioprocess Technology/Bioprocess Analytics.
- You will have experience working with biopharmaceuticals, preferably with therapeutic monoclonal antibody or protein development and manufacture at clinical and/or commercial scale.
- Fluency in English and knowledge of a Scandinavian language are required.
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