Summary: Our client, a biopharmaceutical company located in Dublin, is seeking a Tech Transfer Lead to support drug substance technology transfer activities within a GMP-regulated biologics manufacturing environment. The successful candidate will be responsible for leading technical transfer activities from process development into manufacturing, ensuring robust process understanding, operational readiness, and successful execution across clinical and commercial manufacturing programmes. Responsibilities: Lead end-to-end technology transfer activities supporting drug substance biologics manufacturing processes across internal sites and external manufacturing partners Develop and execute transfer strategies, project plans, timelines, risk assessments, and readiness activities to support successful process transfer Partner closely with Process Development teams to transfer process knowledge, control strategies, critical process parameters, and material attributes into manufacturing operations Coordinate creation, review, and approval of technical transfer documentation including process descriptions, protocols, reports, sample plans, and technical summaries Lead cross-functional transfer teams and drive alignment across Manufacturing, Process Development, Quality, Analytical Sciences, Supply Chain, MSAT, Regulatory, and external partners Support process scale-up, process characterisation, comparability activities, validation strategies, and PPQ campaigns Ensure analytical methods, raw materials, equipment requirements, facility readiness, and manufacturing processes are aligned to support successful transfer execution Lead technical risk assessments and drive mitigation plans through to resolution Support deviation investigations, change controls, CAPA activities, and technical troubleshooting activities associated with transfer execution Provide technical oversight during engineering batches, validation campaigns, and process verification activities Support training and knowledge transfer activities for Manufacturing and Quality teams at receiving sites Monitor post-transfer process performance and drive continuous improvement initiatives to improve robustness and transfer effectiveness Qualifications & Experience: Degree qualification in Biotechnology, Chemical Engineering, Biochemistry, Biology, or a related scientific / engineering discipline Experience working within biologics process development, MSAT, technical services, manufacturing sciences, or technology transfer environments Strong understanding of biologics drug substance manufacturing processes, including upstream and downstream processing operations Experience supporting GMP-regulated biologics manufacturing environments Strong knowledge of process validation, quality systems, technology transfer activities, and manufacturing support Experience leading cross-functional technical projects and collaborating across multiple functional groups Experience supporting clinical and/or commercial technology transfer activities would be advantageous Experience working with external manufacturing partners, CMOs, or CDMOs is preferred Strong stakeholder management, communication, organisation, and problem-solving skills Project Management certification or experience would be advantageous
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