Biologics Tech Transfer Lead

Berkley Group; Dublin; On-site; EUR 90,000 - 140,000; Full time

Job summary

Berkley Life Science & Engineering is seeking a Tech Transfer Lead for Drug Substance Biotech in Ireland to guide end-to-end transfer of biologics manufacturing processes from development to GMP production, including internal sites and external partners.

You will develop transfer strategies, coordinate documentation, lead cross-functional teams, and ensure cGMP compliance while driving continuous improvement in transfer robustness. Travel to partner sites may be required.

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 manufacturing (upstream/downstream).
• 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 skills.
• Ability to travel to site or partner locations as needed.

Responsibilities

• Lead end-to-end technology transfer activities for drug substance biologics processes, including cell culture, upstream and downstream operations, and related unit operations.
• 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, characterization, 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.

Skills

Communication

Organization

Problem-solving

Stakeholder management

Travel readiness

Education

Biology

Biochemistry

Chemical Engineering

Biotechnology

Job description

Berkley Life Science & Engineering is seeking a Tech Transfer Lead for Drug Substance Biotech in Ireland to guide end-to-end transfer of biologics manufacturing processes from development to GMP production, including internal sites and external partners.

You will develop transfer strategies, coordinate documentation, lead cross-functional teams, and ensure cGMP compliance while driving continuous improvement in transfer robustness. Travel to partner sites may be required.