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Junior Tech Transfer Lead – Process Development

Recruitment by Aphex · Dún Laoghaire-Rathdown

Junior 🇬🇧 English
process development process validation sterile processing tech transfer electronic batch record creation process characterisation engineering runs formulation syringe filling CAPA

Job description

About the role

The Junior Tech Transfer Lead will support process development for new biologics product introductions and lifecycle management changes. Working within the global Process Development organisation, the role provides technical expertise for drug product manufacturing and ensures successful technology transfers.

Key responsibilities

  • Lead new product introductions from concept through process performance qualification (PPQ) and regulatory filing.
  • Manage end‑to‑end product transfer projects, including line characterisation, engineering studies, and validation activities.
  • Troubleshoot freeze/thaw, formulation, syringe filling, inspection and transportation issues for parenteral products.
  • Develop documentation, engineering run plans, electronic batch records, validation plans and PPQ protocols for syringe filling.
  • Support commercial manufacturing with change control, NC/CAPA evaluation and technology transfer activities.
  • Ensure compliance with FDA, EU and international regulations and CMC business processes.
  • Participate in cross‑functional validation teams and act as the site point of contact for transfer projects.
  • Travel internationally as required to support project milestones.

Required profile

  • Junior‑level professional with a background in process development for biologics.
  • Experience supporting new product introductions (NPI) and lifecycle management.
  • Ability to manage technology transfer projects from initiation to regulatory approval.
  • Willingness to travel internationally for project support.

Required skills

  • Process development
  • Process validation
  • Sterile processing
  • Tech transfer
  • Electronic batch record creation
  • Process characterisation
  • Engineering run execution
  • Freeze/thaw troubleshooting
  • Formulation expertise
  • Syringe filling operations
  • Change control and CAPA evaluation

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Published 1 month ago

Expires 1 week from now

36 views · 0 interested

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Recruitment by Aphex

Dún Laoghaire-Rathdown