Biotechnology Process Development Manager

2 days ago


Ballerup, Ballerup Kommune, Denmark Unique Human Capital AS Full time
Lead the Purification Team and Drive Downstream Process Development

Join a dynamic biotech team as the Antibody Center of Excellence in Unique Human Capital A/S.

As Purification Team Lead, you will lead a highly skilled team responsible for downstream process development of monoclonal antibodies and novel antibody formats, including bispecifics and ADCs. With direct reporting to Director CMC, Drug Substance Development, you will collaborate with cross-functional teams and external partners to deliver high-quality results.

The key responsibilities include:

  • Timely Material Supply: Support lead candidate selection in the discovery phase by providing timely material supply.
  • In-House Downstream Process Development: Develop processes for early and late-stage clinical stage programs.
  • Technology Transfer: Transfer processes to Contract Manufacturing Organizations (CMOs) and oversee outsourced activities.
  • Process Characterization and Validation: Ensure late-stage programs meet regulatory requirements.
  • Downstream Development Strategy: Contribute to the development strategy, including next-generation antibody formats like bispecific antibodies and ADCs.
  • Purification Scientist/SME: Develop specific tasks and projects related to purification.

To succeed in this role, you must have extensive hands-on experience in downstream process development of antibody products. Managerial experience is ideal, along with knowledge of GMP requirements, regulatory documentation, and collaboration with outsourced activities.

A relevant master's degree in pharmaceuticals, biologics, or similar, and fluency in English are required. You should be proactive, pragmatic, and able to set directions while encouraging initiative and teamwork through coaching management.

Unique Human Capital A/S offers a challenging and versatile job in an innovative environment with strong cross-functional teamwork, opportunities for individual performance and development, and passionate colleagues.



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