Biologics Drug Substance Tech Transfer Lead

ACCPRO; Dublin; Hybrid; EUR 110,000 - 150,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

ACCPRO is seeking a Tech Transfer Lead for Drug Substance to drive end-to-end transfer of biologics manufacturing processes from development to GMP production. You will coordinate cross-functional teams including Process Development, Manufacturing, Quality, and Regulatory, ensuring robust transfer strategies, readiness, and compliance.

The role requires leading activities from cell culture to analytical methods, supporting scale-up, and post-transfer improvements.

Qualifications

• Bachelor’s degree in biology, biochemistry, chemical engineering, biotechnology, or related field.
• 5–8+ years in biologics process development, MSAT, manufacturing, or technology transfer.
• Strong understanding of biologics drug substance manufacturing 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.

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, bill of materials, protocols, reports, and technical summaries.
• Lead cross-functional transfer teams and 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 and 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.

Skills

Cross-functional leadership

Project management

Stakeholder management

Effective communication

Education

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

Master's or PhD preferred

Job description

ACCPRO is seeking a Tech Transfer Lead for Drug Substance to drive end-to-end transfer of biologics manufacturing processes from development to GMP production. You will coordinate cross-functional teams including Process Development, Manufacturing, Quality, and Regulatory, ensuring robust transfer strategies, readiness, and compliance.

The role requires leading activities from cell culture to analytical methods, supporting scale-up, and post-transfer improvements.