Quality Engineer

RECRUITERS; Dublin; Hybrid; EUR 58,000 - 95,000; Full time

Job summary

RECRUITERS is seeking a Tech Transfer Lead for Biologics Drug Substance in Swords, Dublin. This hybrid role leads technology transfer from development to GMP manufacturing, coordinating with development, manufacturing and external partners to ensure timely, compliant transfers for clinical and commercial production.

The role requires 5–8+ years in biologics transfer, cGMP experience, and strong cross-functional leadership.

Qualifications

• Bachelor's degree in Biology, Biochemistry, Chemical Engineering, Biotechnology or a related 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.
• 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.

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.

Skills

Communication

Organization

Problem solving

Stakeholder management

Project management

Education

Bachelor's degree in Biology/Biochemistry/Engineering/Biotechnology

Master's degree or PhD in a relevant discipline

Job description

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.
• 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.