CMC Technical Integration Specialist

1 month ago


Copenhagen, Copenhagen, Denmark Genmab AS Full time
About the Role

We are seeking a highly skilled Senior CMC Technical Integration Manager to join our CMC Integration Team in New Product Introduction (NPI) CMC. As a key member of the team, you will be responsible for developing and supporting analytical/process strategies for selected projects in the Genmab Early-Stage project portfolio.

Key Responsibilities
  1. Integration of new/specific required analytical/process strategies into CMC Development Path deviating from Genmab CMC platform.
  2. Managing specific analytical/process activities at CMOs related to Early-Stage projects, ensuring technical excellence and speed into First-in-Human trials.
  3. Support 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.
  4. Support authoring and reviewing of regulatory CMC submissions (IND/CTA).
  5. Supporting and following up on CMO and internal quality events such as changes or deviations.
Requirements
  • Proven track record and technical skills of biological process or analytical development and biopharmaceutical manufacturing.
  • Very good knowledge of the principles of GMP and CMC development within the biopharmaceutical industry.
  • At least 4-8 years of working experience with biopharmaceuticals, preferably with therapeutic monoclonal antibody or protein development and manufacture at clinical and/or commercial scale.
  • Additional experience from antibody drug conjugate projects or chemical engineering/API technology or new antibody formats is an advantage.
  • Fluent in English and (preferably) knowledge of a Scandinavian language.
  • Basic knowledge of Project Management tools.


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