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Biopharmaceuticals Development Specialist

1 week ago

Copenhagen, Copenhagen, Denmark Genmab AS Full time

At Genmab, we are committed to developing extraordinary futures together by pioneering therapies that change the lives of patients and the future of cancer treatment. We believe in building a diverse team of passionate professionals who are dedicated to making a meaningful impact.

The Role

We are seeking a skilled Biopharmaceuticals Development Specialist to join our CMC Integration Team in New Product Introduction (NPI) CMC. As part of our team, you will be responsible for integrating analytical/process strategies into CMC development paths deviating from our CMC platform.

You will work closely with our CMC PM team to solve project-specific analytical/process tasks with a holistic CMC approach for new antibody modalities or CMC challenges like transfer to new manufacturing sites. Your expertise in biological process or analytical development and biopharmaceutical manufacturing will be invaluable in ensuring technical excellence 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 CMOs related to Early-Stage projects, ensuring technical excellence and speed into First-in-Human trials.
  • Supporting the CMC PM to solve project-specific analytical/process tasks with a holistic CMC approach for new antibody modalities or CMC challenges like transfer to new manufacturing sites.