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Technical Manufacturing Expert

1 week ago

County Dublin, Ireland Tandem Project Management Limited Full time
Role Overview:

We are seeking a highly skilled Technical Manufacturing Expert to join our team at Tandem Project Management Limited.

The successful candidate will provide expert advice on process development, review, and approval of process, buffer, and media electronic batch records (EBR).

This role requires strong communication and collaboration skills to work effectively with colleagues in Quality, Supply Chain, and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.

The incumbent will be responsible for identifying and implementing process improvements, e.g., yield and cycle time reduction.

  • 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).
  • Lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale.
  • Collaborate with global groups to implement corporate standards and ensure compliance with site EHS policy, cGMP, and other business regulations.

Candidates will require 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.