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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 acts 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 transfer activities
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