CMC Project Lead

1 week ago


Copenhagen, Copenhagen, Denmark Genmab AS Full time

Genmab is an international biotechnology company committed to improving the lives of patients through innovative and differentiated antibody therapeutics. We strive to build extraordinary futures together by inventing next-generation antibody technology platforms and leveraging translational research and data sciences.

The Job Description

We are seeking a (Senior) CMC Technical Integration Manager to join our team in New Product Introduction (NPI) CMC. Your primary responsibility will be to develop and support analytical/process strategies for selected projects, ensuring 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. Experience in running projects with external partners is preferred.

  • You will manage specific analytical/process activities at 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 Us

  • We are a fast-growing, dynamic company with a strong desire to make a difference in the lives of patients.
  • We leverage the effectiveness of an agile working environment for the betterment of employee work-life balance.

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