Biopharmaceutical Process Specialist

5 days ago


County Dublin, Ireland Tandem Project Management Limited Full time
Job Description:

A Biopharmaceutical Process Specialist is required to support the technology transfer, process validation, and routine commercial manufacturing for Upstream and Downstream manufacturing.

The successful candidate will provide processing expertise to support the technology transfer of new and existing drug substance (DS) manufacturing processes to site.

This role involves working in close collaboration with other departments and Contract Manufacturing Organisation (CMO) to ensure the successful introduction of new raw materials and consumables.

The incumbent will be responsible for development, review, and approval of process, buffer, and media electronic batch records (EBR).

  • Provide process support in one or both of the following disciplines: upstream (media preparation, large-scale cell culture bulk drug substance manufacturing process) and downstream (buffer preparation, purification, and viral reduction).
  • Develop, review, and approve process, buffer, and media electronic batch records (EBR).
  • Author and review process transfer documentation, gap assessments, technical protocols, and reports, and process validation documentation, strategy documents.

The ideal candidate will have a comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing and experience of technology transfer activities.

Skillful candidates will possess strong technical writing competency, comprehensive knowledge of multiple unit operations in cell culture processing, and experience in EBR and manufacturing support in a biological bulk drug substance manufacturing organization.



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