Tech Transfer Lead (Drug Substance) TPM6143

Tandem Project Management; Dublin; Remote; EUR 90,000 - 130,000; Full time

Job summary

Tandem Project Management Ltd. is seeking a Tech Transfer Lead in Dublin to lead the transfer of biologics drug substance manufacturing processes from development or sending sites into GMP manufacturing.

You will ensure robust technical transfer, process understanding, and readiness for clinical and commercial production. The role requires collaboration with Process Development, Manufacturing, Quality, Analytical, Regulatory and external partners, along with travel as needed to support

Qualifications

• Bachelor’s degree in biology/biochemistry/chemical engineering/biotechnology or related field.
• Typically 5–8+ years in biologics process development, manufacturing science, technology transfer or related.
• Experience with biologics drug substance manufacturing, including upstream and downstream processing.
• Knowledge of cGMP regulations, process validation and quality systems.

Responsibilities

• Lead end-to-end technology transfer for biologics drug substance processes, including cell culture and upstream/downstream operations.
• Develop transfer strategies, project plans, timelines and readiness assessments.
• Coordinate creation, review and approval of transfer documentation (process descriptions, protocols, reports).
• Lead cross-functional transfer teams and governance meetings to align scope, milestones and risks.
• Support scale-up, comparability, and process validation activities as required.

Skills

Tech transfer

Project management

Cross-functional collaboration

Regulatory knowledge

cGMP

Process validation

Education

Bachelor’s degree in Biology/ biochemistry/ chemical engineering/ biotechnology or related field

Job description

Summary:

A biopharmaceutical company in Dublin is seeking a Tech Transfer Lead to lead the transfer of biologics drug substance manufacturing processes from process development or sending sites into GMP manufacturing, including internal sites and external manufacturing partners. The successful candidate will ensure robust technical transfer, process understanding and operational readiness for clinical and commercial production, working closely with Process Development, Manufacturing, Quality, Analytical, Supply Chain, Manufacturing Science and Technology, Regulatory and external manufacturing teams.

Responsibilities:

• Lead end-to-end technology transfer activities for drug substance 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, bills 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, characterisation, 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, Process Performance Qualification (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, global and sending-site stakeholders to ensure accountability and timely issue resolution.

Qualifications & Experience:

• Bachelor’s degree in Biology, Biochemistry, Chemical Engineering, Biotechnology, or related scientific/engineering discipline.
• Typically 5–8+ years of experience in biologics process development, manufacturing science and technology, 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.
• Ability to travel as needed to support site-to-site or partner transfers.
• Master’s degree or PhD in a relevant discipline is desirable.
• Experience with monoclonal antibodies, recombinant proteins, or other biologic modalities is desirable.
• Experience with external manufacturing partners, contract manufacturing organisations (CMOs) or contract development and manufacturing organisations (CDMOs) is desirable.
• Familiarity with process characterisation, scale-down models, and comparability assessments is desirable.
• Experience supporting clinical and/or commercial tech transfers is desirable.
• Project management experience or certification is desirable.