Tech Transfer Lead – Intermediate (Biotech)

About the role

Our client, a global biotechnology company based in South Dublin, is looking for an Intermediate Tech Transfer Lead to support new product introductions, lifecycle management and commercial biologics manufacturing. The role will also contribute to the transition to a new facility with single‑use processing and syringe‑filling lines.

Key responsibilities

• Lead new product introductions from concept through technology transfer, line characterisation, engineering studies, Process Performance Qualification (PPQ), regulatory filing and approval.
• Develop process designs and documentation for characterisation studies, engineering runs, electronic batch records, validation plans and syringe‑filling PPQ activities.
• Provide technical support and troubleshooting across drug substance freeze‑thawing, formulation, filtration, syringe filling, inspection and transportation processes.
• Support commercial drug product manufacturing by evaluating change controls, non‑conformances, deviations and CAPAs.
• Ensure all process validation activities comply with safety, training and regulatory standards (FDA, EU, etc.).
• Act as site point of contact for assigned transfer projects, coordinating with global operations, sending and receiving sites and corporate functions.
• Participate in cross‑functional validation teams, review and approve validation protocols and related quality‑system documentation.
• Assist with deviation resolution, root‑cause analysis and continuous improvement initiatives.

Required profile

• Bachelor’s degree in Science, Engineering or related discipline with at least four years’ experience in commercial manufacturing or NPI.
• Master’s degree with at least two years of directly relevant experience, or Associate degree with at least seven years of directly relevant experience.
• Demonstrated ability to manage technology transfer projects and meet defined milestones.

Required skills

• Process Performance Qualification (PPQ)
• Electronic batch records
• Syringe‑filling operations
• Freeze‑thawing of drug substance
• Formulation development
• Filtration processes
• Inspection and transportation processes
• Process validation
• Regulatory filing