Tech Transfer Lead – Drug Substance

Ref. 1389

Tech Transfer Lead – Drug Substance

Our client, a multinational pharmaceutical company with a strong presence in Ireland, is seeking a Tech Transfer Lead – Drug Substance to join their team at their Swords, Dublin site.

The Tech Transfer Lead – Drug Substance is responsible for leading the transfer of drug substance manufacturing processes from Process Development or sending site into GMP manufacturing operations, including both internal facilities and external manufacturing partners. As part of the MS&T team, this role ensures effective technology transfer, strong process understanding, and manufacturing readiness for the clinical and commercial production of biologics.

The position act as a key cross-functional liaison between Process Development, Manufacturing, Quality, Analytical, Supply Chain, MSAT, Regulatory, and CDMOs to ensure transfers are executed successfully, compliantly, and within project timelines.

Responsibilities:
• Lead end-to-end technology transfer activities for drug substance biologics processes, including cell culture, upstream and downstream operations, and related unit operations
• Create and execute transfer strategies, project plans, timelines, risk assessments, and readiness assessments
• Coordinate creation, review, and approval of transfer documentation, including process descriptions, sample plans, bill of materials, protocols, reports, and technical summaries
• Coordinate with process development teams to transfer process knowledge, critical process parameters, control strategy, and material attributes into manufacturing
• 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
• Support deviation investigations, change controls, and CAPA activities related to transfer execution
• Coordinate with Quality and Regulatory functions to ensure compliance with cGMP, internal procedures, and applicable regulatory expectations
• 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
• Manage communication with internal & above site/sending unit stakeholders to ensure accountability and timely issue resolution
• Monitor post-transfer performance and lead continuous improvement initiatives to improve process robustness and transfer effectiveness

Requirements:
• Bachelor’s degree in Biology, Biochemistry, Chemical Engineering, Biotechnology, or a related scientific/engineering discipline
• 5–8+ years of experience in biologics process development, MSAT, manufacturing, or technology transfer
• Knowledge of cGMP regulations, process validation, and quality systems in a regulated biotech environment
• Solid understanding of drug substance manufacturing for biologics, including upstream and downstream processing
• Proven experience leading cross-functional projects and technical teams
• Excellent communication, organization, problem-solving, and stakeholder management skills
• Ability to travel as needed to support site-to-site or partner transfers

Desired Qualifications:
• Master’s degree or PhD in a relevant discipline
• Experience with monoclonal antibodies, recombinant proteins, or other biologic modalities
• Project management experience or certification
• Exposure to external manufacturing partners, CMOs, or CDMOs
• Familiarity with process characterization, scale-down models, and comparability assessments
• Experience supporting clinical and/or commercial tech transfers activities