Senior Process Development Lead

4 days ago


Dublin, Dublin City, Ireland TN Ireland Full time

The role of the Senior Process Development Lead at TN Ireland will provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes.

As a key member of the Process Development organization, you will establish yourself in a product lead role where the majority of input provided will be leading of process performance qualification (PPQ).

You will provide technical support to biologics drug product manufacturing as part of the global Process Development organization.

Leads new product introductions from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer.

Be accountable for success of the product transfer project from initiation to the transfer, through line characterisation, engineering studies, process performance qualification and ultimately to regulatory approval.

Provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection and transportation for parenteral products through the NPI or post-NPI phases.



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