Technical Manager
4 days ago
We are seeking a highly skilled CMC Technical Integration Manager to join our team in New Product Introduction (NPI) CMC. As a key member of the CMC Integration Team, you will be responsible for developing and supporting analytical/process strategies for selected projects in the Genmab Early-Stage project portfolio.
Your primary focus will be on integrating these strategies into projects where the CMC development path deviates from the Genmab CMC platform. You will work closely with cross-functional teams to ensure technical excellence, regulatory compliance, and speed into First-in-Human trials.
Key Responsibilities Include:
- Integration of new/specific required analytical/process strategies into CMC Development Path deviating from Genmab CMC platform.
- Managing specific analytical/process activities at Contract Manufacturing Organizations (CMOs) related to Early-Stage projects.
- Supporting the CMC Project Management team to solve project-specific analytical/process tasks.
About You
- You should bring a broad background from CMC development within Bioprocess Technology/Bioprocess Analytics.
- You have a proven track record and technical skills in biological process or analytical development and biopharmaceutical manufacturing.
- Very good knowledge of the principles of Good Manufacturing Practice (GMP) and CMC development within the biopharmaceutical industry.
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