Junior Technology Transfer Lead

We are currently recruiting for an opportunity with a leading global biologics manufacturer based in South Dublin.

The position will support new product introductions and lifecycle management changes within a commercial aseptic drug product facility. The successful candidate will work across product transfer, process development, engineering studies, process characterisation and PPQ, with particular focus on new syringe filling and single-use processing capabilities.

This would suit a Process Development, MSAT, Validation or Technology Transfer Engineer looking to take greater ownership of commercial product-transfer projects.

Duties

• Support and lead new product introductions from initial concept through engineering studies, PPQ, product filing and regulatory approval.
• Coordinate product-transfer activities between sending sites, receiving-site functions and global drug product teams.
• Develop process designs and documentation for characterisation studies, engineering runs and validation activities.
• Author and review validation plans, protocols, assessments, technical reports and process performance qualification documentation.
• Support electronic batch record creation for syringe filling processes.
• Provide technical troubleshooting support across drug substance freeze-thaw, formulation, filtration, mixing, syringe filling, inspection and product transportation.
• Support process characterisation and validation of commercial protein drug product processes.
• Review Change Controls, deviations, non-conformances and CAPAs from a Process Development perspective.
• Support root-cause investigations and the implementation of technically robust corrective actions.
• Pre-approve and post-approve process validation protocols and assessments.
• Support shipping validation, filter validation and product quality assessments.
• Contribute to process flow documents, technical risk assessments and site validation guidance.
• Work closely with Manufacturing, Quality, Engineering, Regulatory, Supply Chain and global technical teams.
• Act as a site point of contact for assigned drug product transfer projects.

• Bachelor’s degree in Science, Engineering or a related discipline with at least two years of relevant commercial manufacturing or NPI experience.
• Alternatively, a Master’s degree with at least one year of directly related experience.
• Strong knowledge of cGMP and international regulatory requirements.
• Demonstrated technical writing and documentation skills.
• Experience supporting process validation, technology transfer or new product introduction activities.

• Commercial biologics or protein drug product manufacturing.
• Sterile processing or aseptic fill-finish.
• Prefilled syringe filling.
• Formulation, freeze-thaw, mixing or sterile filtration.
• Process characterisation and PPQ.
• Shipping or filter validation.
• CMC documentation and regulatory filing support.
• Change Control, deviation investigation and CAPA management.