Biologics Tech Transfer Lead - Scale-Up Expert

Morgan McKinley; Dublin; Híbrido; EUR 120.000 - 180.000; Tempo integral

Resumo da vaga

Morgan McKinley is seeking a Tech Transfer Lead in Ireland to drive transfer of drug substance biologics from development to GMP manufacturing. You will coordinate cross-functional teams across Process Development, Manufacturing, Quality, Analytical, and Regulatory to ensure robust transfer and readiness for clinical and commercial production.

The role requires 5–8+ years in biologics process development or tech transfer, deep cGMP knowledge, and strong project management.

Qualificações

• Bachelor's degree in biology, biochemistry, chemical engineering, biotechnology, or related field.
• 5–8+ years of experience in biologics process development, MSAT, manufacturing, or tech transfer.
• Strong understanding of drug substance manufacturing for biologics.
• Knowledge of cGMP regulations, process validation, and quality systems.
• Experience leading cross-functional projects and technical teams.
• Excellent communication, organization, problem-solving, and stakeholder management.
• Ability to travel as needed for site-to-site or partner transfers.

Responsabilidades

• Lead end-to-end technology transfer for biologics processes from development to GMP manufacturing.
• Develop transfer strategies, project plans, timelines, and risk assessments.
• Coordinate creation and approval of transfer documents.
• Lead cross-functional transfer teams and governance meetings.
• Support process scale-up, comparability, and validation activities.
• Ensure analytical methods, sampling plans, materials meet transfer requirements.
• Monitor post-transfer performance and pursue continuous improvement.
• Communicate with stakeholders to ensure accountability and timely issue resolution.

Conhecimentos

Biologics process

MSAT

Technology transfer

Cross-functional leadership

cGMP knowledge

Regulatory knowledge

Project management

Communication skills

Travel readiness

Formação

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

MS/PhD preferred

Descrição da vaga

Morgan McKinley is seeking a Tech Transfer Lead in Ireland to drive transfer of drug substance biologics from development to GMP manufacturing. You will coordinate cross-functional teams across Process Development, Manufacturing, Quality, Analytical, and Regulatory to ensure robust transfer and readiness for clinical and commercial production.

The role requires 5–8+ years in biologics process development or tech transfer, deep cGMP knowledge, and strong project management.