Tech Transfer Lead

Recruitment by Aphex; Dublin; Sur place; EUR 120 000 - 165 000; Plein temps

Résumé du poste

Aphex Group is seeking a Tech Transfer Lead for Drug Substance Biologics in Ireland. You will lead end-to-end technology transfer from development or sending unit into GMP manufacturing, coordinating cross-functional teams across Process Development, Manufacturing, Quality, and Regulatory.

This role ensures robust transfer, process understanding and readiness for clinical and commercial production. The ideal candidate has 5–8+ years in biologics, strong cGMP knowledge, and proven project

Qualifications

• Bachelor's degree in biology, biochemistry, chemical engineering, biotechnology or related field.
• 5–8+ years in biologics process development, MSAT, manufacturing or tech transfer.
• Strong understanding of biologics drug substance manufacturing (upstream/downstream).
• Familiarity with cGMP, process validation and quality systems in biotech.
• Experience leading cross-functional projects and teams.
• Excellent communication, organization, and stakeholder management skills.

Responsabilités

• Lead end-to-end tech transfer activities for biologics drug substance processes.
• Develop and execute transfer strategies, plans, timelines and risk assessments.
• Coordinate creation and approval of transfer documentation (descriptions, plans, BOMs, protocols).
• Lead cross-functional transfer teams and governance meetings.
• Support scale-up, characterization, comparability and validation activities.
• Ensure analytical methods, sampling plans, materials and facilities support transfer.
• Identify risks and drive mitigation actions.
• Collaborate with Quality and Regulatory to ensure cGMP compliance.
• Support deviations, change controls and CAPA related to transfers.
• Provide technical oversight during PPQ or verification campaigns.
• Support training and knowledge transfer to manufacturing/QA.

Connaissances

Cross-functional leadership

Communication

Problem solving

Travel readiness

Formation

Bachelor's degree in Biology/Engineering

Master's or PhD preferred

Description du poste

Tech Transfer Lead, Drug Substance

Purpose

The Tech Transfer Lead, Drug Substance Biotech, is responsible for leading the transfer of drug substance manufacturing processes from process development or sending unit into GMP manufacturing, including internal sites and external manufacturing partners. This role with the MS&T team ensures robust technical transfer, process understanding, and operational readiness for clinical and commercial production of biologics. The position serves as a key cross-functional interface among Process Development, Manufacturing, Quality, Analytical, Supply Chain, MSAT, Regulatory, and CDMOs to deliver successful, compliant, and timely transfers.

Responsibilities

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

Required Qualifications

• Bachelor's degree in Biology, Biochemistry, Chemical Engineering, Biotechnology, or related scientific/engineering discipline
• Typically 5-8+ years of experience in biologics process development, MSAT, manufacturing, or technology transfer
• Strong understanding of drug substance manufacturing for biologics, including upstream and downstream processing
• Knowledge of cGMP regulations, process validation, and quality systems in a regulated biotech environment
• Demonstrated 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

Preferred Qualifications

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