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

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.

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

Required

• 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

Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-group.com.