Tech Transfer Lead Hybrid RK26146 Contract 11 months Dublin Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. The Tech Transfer Lead, Drug Substance, is responsible for leading the transfer of drug substance manufacturing processes from process development or sending unit into GMP manufacturing, including internal sites and external manufacturing partners. Key Responsibilities: Lead end-to-end technology transfer activities for drug substance biologics processes, including cell culture, upstream and downstream operations, and related unit operations Develop and execute transfer strategies, project plans, timelines, risk assessments, and readiness assessments Partner with process development teams to transfer process knowledge, critical process parameters, control strategy, and material attributes into manufacturing Coordinate creation, review, and approval of transfer documentation, including process descriptions, sample plans, bill of materials, protocols, reports, and technical summaries Lead cross-functional transfer teams and facilitate regular governance meetings to ensure alignment on scope, milestones, and risks Support process scale-up, characterization, comparability, and process validation activities as required Ensure analytical methods, sampling plans, raw materials, equipment, and facility requirements are aligned to support successful transfer Identify technical and operational risks and drive mitigation plans to resolution Partner with Quality and Regulatory functions to ensure compliance with cGMP, internal procedures, and applicable regulatory expectations Support deviation investigations, change controls, and CAPA activities related to transfer execution Provide technical oversight during engineering batches, PPQ, or process verification campaigns Support training and knowledge transfer to manufacturing and quality teams at the receiving site Monitor post-transfer performance and lead continuous improvement initiatives to improve process robustness and transfer effectiveness Manage communication with internal & above site/sending unit stakeholders to ensure accountability and timely issue resolution Education and Experience: Bachelors degree in Biology, Biochemistry, Chemical Engineering, Biotechnology, or related scientific/engineering discipline Typically 5 - 8+ years of experience in biologics process development, MSAT, manufacturing, 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 with external manufacturing partners, CMOs, or CDMOs Familiarity with process characterization, scale-down models, and comparability assessments If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
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