Biotech Drug Substance Tech Transfer Lead

Aphex Group; Dublin; On-site; EUR 120,000 - 165,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Cross-functional leadership

Communication

Problem solving

Travel readiness

Education

Bachelor's degree in Biology/Engineering

Master's or PhD preferred

Job description

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