Biologics Tech Transfer Lead – Drug Substance

PSC Biotech® Corporation; Ireland; Hybrid; EUR 80,000 - 140,000; Full time

Job summary

PSC Biotech is seeking a Tech Transfer Lead, Drug Substance Biotech, to drive end-to-end transfer of biologics manufacturing processes from development to GMP production across internal sites and external partners.

You will lead cross-functional teams with Process Development, Manufacturing, Quality, Analytical, Regulatory, and MSAT to ensure robust transfer, readiness, and compliance for clinical and commercial production.

Qualifications

• Bachelor’s degree in Biology, Biochemistry, Chemical Engineering, Biotechnology, or related scientific/engineering discipline.
• Typically 5–8+ years of 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.

Responsibilities

• Lead end-to-end technology transfer activities for 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, 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

Strong communication

Problem solving

Stakeholder management

Travel ability

Education

Bachelor’s degree in Biology, Biochemistry, Chemical Engineering, Biotechnology, or related field

Job description

PSC Biotech is seeking a Tech Transfer Lead, Drug Substance Biotech, to drive end-to-end transfer of biologics manufacturing processes from development to GMP production across internal sites and external partners.

You will lead cross-functional teams with Process Development, Manufacturing, Quality, Analytical, Regulatory, and MSAT to ensure robust transfer, readiness, and compliance for clinical and commercial production.