Technology Transfer Specialist

Job Title: Tech Transfer Lead

Location: Ireland

Working Arrangement: Hybrid – 3 days onsite per week

Start Date: First week of January 2027 (fixed start date)

Position Summary

We are seeking an experienced Tech Transfer Lead – Drug Substance Biotech to lead technology transfer activities for biologics manufacturing processes, supporting a new technology transfer project.

The successful candidate will drive the transfer of drug substance manufacturing processes from process development or sending units into GMP manufacturing facilities, including internal sites and external manufacturing partners.

Working closely with MS&T and cross-functional teams, the role will ensure successful, compliant and timely technology transfers, with a strong focus on process understanding, technical readiness and operational execution.

Key Responsibilities

• Lead end-to-end technology transfer activities for drug substance biologics processes, including upstream, cell culture, downstream operations and analytical methods.
• Develop and execute technology transfer strategies, project plans, timelines, risk assessments and readiness assessments.
• Work closely 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, protocols, reports, sample plans and technical summaries.
• Lead cross-functional project teams and facilitate governance meetings to track 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 aligned for successful technology transfer.
• Identify technical and operational risks and implement appropriate mitigation strategies.
• Collaborate with Quality and Regulatory teams to ensure compliance with cGMP requirements and applicable regulatory guidelines.
• Support deviation investigations, change controls and CAPA activities associated with technology transfer.
• Provide technical oversight during engineering batches, PPQ and process verification campaigns.
• Support training and knowledge transfer to manufacturing and quality teams.
• Monitor post-transfer performance and drive continuous improvement initiatives.
• Manage communication with internal and external stakeholders to ensure timely issue resolution and successful project delivery.

Required Qualifications and Experience

• Bachelor's degree in Biology, Biochemistry, Chemical Engineering, Biotechnology or a related scientific or engineering discipline.
• Typically 8+ years of experience in biologics process development, MS&T, manufacturing or technology transfer.
• Strong understanding of biologics drug substance manufacturing, including upstream and downstream processing.
• Experience working within cGMP-regulated pharmaceutical or biotechnology environments.
• Knowledge of process validation, quality systems and regulatory requirements.
• Demonstrated experience leading cross-functional technical projects and teams.
• Excellent communication, organisational, problem-solving and stakeholder management skills.
• Flexibility to travel when required to support site-to-site or external partner transfers.

Preferred Experience

• Previous experience in New Product Introduction (NPI) and/or the Biopharma industry will be highly advantageous and preferred during shortlisting.
• Master's degree or PhD in a relevant scientific or engineering 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 relevant certification.

Important Role Requirements

• Hybrid working arrangement with 3 days onsite per week.
• At least one onsite day must be either Monday or Friday.