Biotechnology Manufacturing Expert

5 days ago


County Dublin, Ireland Pe Global Full time

The role of a Technical Services Specialist at Pe Global involves supporting the cGMP manufacture of biological bulk drug substance (BDS). The specialist will provide processing expertise to support technology transfer, process validation, and routine commercial manufacturing for Downstream manufacturing.

The specialist will be responsible for providing support for new/existing drug substance (DS) manufacturing processes at the Dublin facility. They will work in close collaboration with Process Development, DS Process Sending unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory, and other involved departments to ensure successful facility startup and process qualification.

Key responsibilities include providing process expertise in Downstream purification process, authoring and reviewing technical documentation, leading continuous process verification programs, and supporting the introduction of new raw materials and consumables.

The specialist must have comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing and experience of technology transfer activities is advantageous. Additionally, knowledge or experience of start-up or systems would be ideal.



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