Quality Engineer

Tech Transfer Lead – Drug Substance Biotech

• Contract: 12 months.
• Salary: €58,000–€95,000 per annum, depending on experience.
• Location: Swords, Co. Dublin.
• Working arrangement: Hybrid, with 3 days onsite per week. One onsite day must be either Monday or Friday.
• Working hours: Days only, no night shifts.
• Start date: 4 January 2027 (fixed start date; alternative start dates cannot be accommodated).

We are recruiting two Tech Transfer Leads for a leading pharmaceutical/biotechnology company based in Swords, Co. Dublin. This role will lead the technology transfer of biologics drug substance manufacturing processes from development into GMP manufacturing, working closely with cross-functional teams and external manufacturing partners. You will play a key role in ensuring successful, compliant and timely transfers to support clinical and commercial production.

Key Responsibilities

• Lead end-to-end technology transfer activities for biologics drug substance processes, covering cell culture, upstream and downstream operations, and analytical methods.
• Develop and manage transfer strategies, project plans, timelines, risk assessments and readiness assessments.
• Work with Process Development teams to transfer process knowledge, critical process parameters, control strategies and material attributes into manufacturing.
• Coordinate the preparation, review and approval of transfer documentation, including process descriptions, sample plans, bills of materials, protocols and reports.
• Lead cross-functional project teams and facilitate governance meetings to track progress, milestones, risks and deliverables.
• Support process scale-up, characterisation, comparability and process validation activities.
• Ensure analytical methods, sampling plans, raw materials, equipment and facility requirements are in place for successful transfers.
• Identify technical and operational risks and drive mitigation plans through to resolution.
• Work with Quality and Regulatory teams to ensure compliance with cGMP, internal procedures and regulatory expectations.
• Support deviation investigations, change controls and CAPA activities related to technology transfer.
• Provide technical oversight during engineering batches, PPQ and process verification campaigns.
• Support training and knowledge transfer for manufacturing and quality teams at the receiving site.
• Monitor post-transfer performance and lead continuous improvement initiatives.
• Maintain communication with internal and sending-site stakeholders to ensure accountability and timely issue resolution.

Requirements

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

Desirable

• Master's degree or PhD in a relevant discipline.
• Experience with monoclonal antibodies, recombinant proteins or other biologic modalities.
• Experience working with external manufacturing partners, CMOs or CDMOs.
• Familiarity with process characterisation, scale-down models and comparability assessments.
• Experience supporting clinical and/or commercial technology transfers.
• Project management experience or certification.

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