Junior Tech Transfer Lead

About the role

The Tech Transfer Lead (Junior) will support process development for new product introductions and lifecycle management at a leading multinational pharma client in South Dublin. The role involves technical support for biologics drug product manufacturing and participation in 24/7 on‑call support as needed.

Key responsibilities

• Lead new product introductions from concept to PPQ, ensuring successful product filings and regulatory approval.
• Provide technical solutions for drug substance freeze/thaw, formulation, syringe filling, inspection and transportation.
• Develop documentation, engineering runs, electronic batch records, validation plans and process performance qualifications for syringe filling.
• Support commercial manufacturing with change control, CAPA and technology transfer activities.

Required profile

• Bachelor’s degree in science/engineering with 2 years commercial manufacturing or NPI experience (or equivalent Master’s/Associate’s qualifications).
• Strong technical writing, problem‑solving and communication skills.
• Experience in sterile processing, process characterization, tech transfer or validation of protein drug products.
• Project management ability to handle multiple projects and lead cross‑functional teams.

Required skills

• cGMP knowledge and worldwide regulatory requirements (FDA, EU, etc.).
• Protein freeze‑thaw, filtration, mixing and filling expertise.
• Process characterization and validation techniques.
• Electronic batch record creation and validation planning.