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Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

Junior Technology Transfer Lead


Reference:SMC0385 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Process Engineer

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.

Education and Experience

  • 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.

Desirable Experience

  • 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.

Some international travel may be required.
For further information, please contact Seán McCarthy on +353 (0)87 798 8480 or [email protected].