Tech Transfer Lead

About the role

The Tech Transfer Lead for Drug Substance will drive the transfer of biologics manufacturing processes from development to GMP production across internal sites and external partners. This hybrid role based in Dublin offers the chance to work with a leading multinational pharmaceutical organization.

Key responsibilities

• Lead end‑to‑end technology transfer of cell‑culture, upstream and downstream biologics processes.
• Develop and execute transfer strategies, project plans, timelines, risk and readiness assessments.
• Coordinate creation, review and approval of transfer documentation (process descriptions, sample plans, bill of materials, protocols, reports, technical summaries).
• Partner with process development, Quality and Regulatory to ensure cGMP compliance and alignment of analytical methods, raw materials, equipment and facilities.
• Support scale‑up, characterization, comparability, and process validation activities.
• Identify technical and operational risks, drive mitigation plans and oversee deviation investigations, change controls and CAPA.
• Provide technical oversight during engineering batches, PPQ and process verification campaigns.
• Facilitate training, knowledge transfer and post‑transfer performance monitoring to drive continuous improvement.

Required profile

• Bachelor’s degree in Biology, Biochemistry, Chemical Engineering, Biotechnology or a related scientific discipline.
• 5–8+ years of experience in biologics process development, manufacturing, MSAT or technology transfer.
• Strong understanding of drug substance manufacturing for biologics, including upstream and downstream processing.
• Knowledge of cGMP regulations, process validation and quality systems in a regulated biotech environment.
• Experience working with external manufacturing partners, CMOs or CDMOs.
• Familiarity with process characterization, scale‑down models and comparability assessments.

Required skills

• Cell culture
• Upstream processing
• Downstream processing
• Process validation
• cGMP compliance
• Analytical methods
• Risk assessment
• Process characterization
• Scale‑down models
• Comparability assessments
• Engineering batch execution
• Process performance qualification (PPQ)
• Process verification
• Technology transfer documentation
• Project planning