Junior Tech Transfer Lead

About the role

This position supports new product introductions, lifecycle management and the transfer of biologics drug product processes into a world‑class manufacturing site in South Dublin. The junior lead will work from initial planning through process characterization, engineering studies, process performance qualification (PPQ) and regulatory filing.

Key responsibilities

• Lead and support new product introductions from concept through PPQ and regulatory filing.
• Coordinate product transfer activities, including process characterization, engineering runs, validation and regulatory approval.
• Develop technical documentation, electronic batch records, validation plans and syringe‑filling PPQ activities.
• Provide technical support for freeze‑thaw, formulation, filtration, syringe filling, visual inspection and transportation processes.
• Support commercial drug‑product manufacturing, sterile processing, process validation and technology transfer.
• Contribute to change controls, non‑conformances, deviations, CAPAs and root‑cause analysis.
• Participate in cross‑functional validation teams and ensure compliance with safety, training and regulatory standards.
• Act as site contact for assigned transfer projects and assist with deviation investigations and product quality assessments.

Required profile

• Bachelor’s degree in Science, Engineering or related field with ≥2 years relevant experience, or Master’s with ≥1 year, or Associate with ≥5 years.

Required skills

• Process characterization and engineering studies
• Process validation and PPQ execution
• Regulatory filing and documentation
• Electronic batch record creation
• Freeze‑thaw handling, formulation and filtration
• Syringe filling and visual inspection
• Change control, deviation handling and CAPA management
• Root‑cause analysis and quality‑system documentation

What we offer

• Opportunity to work on life‑changing medicines in a global biotech environment
• Exposure to cutting‑edge single‑use processing technologies
• Collaborative cross‑functional teams across global operations