Tech Transfer Lead

Orion Group; Dublin; Hybrid; EUR 110,000 - 150,000; Full time

Job summary

Orion Group Life Sciences is seeking a Tech Transfer Lead for Drug Substance in Dublin on a 12‑month hybrid contract.

You will lead end‑to‑end technology transfer from development to GMP manufacturing and coordinate cross‑functional teams across Process Development, Manufacturing, Quality, Analytical, Supply Chain, MSAT, Regulatory, and CDMOs to ensure timely, compliant transfers for clinical and commercial production of biologics.

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 knowledge of drug substance manufacturing for biologics (upstream/downstream).
• Experience with cGMP, process validation, and quality systems.
• Proven ability to lead cross-functional projects and teams.
• Excellent communication and stakeholder management skills.
• Willingness to travel as needed for site-to-site transfers.

Responsibilities

• Lead end-to-end technology transfer activities for drug substance biologics processes (cell culture, upstream, downstream, analytical).
• Develop and execute transfer strategies, plans, timelines, risk assessments, readiness assessments.
• Partner with development teams to transfer process knowledge and critical parameters.
• Coordinate creation, review, and approval of transfer docs (descriptions, plans, BOMs, protocols).
• Lead cross-functional transfer teams and governance meetings for scope and milestones.
• Support process scale-up, characterization, comparability, and validation activities.
• Ensure analytical methods, sampling plans, and materials align with transfers.
• Identify risks and drive mitigation plans to resolution.
• Collaborate with Quality and Regulatory for cGMP compliance.

Skills

Cross-functional collaboration

Communication

Problem-solving

Stakeholder management

Travel readiness

Education

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

Job description

Orion Group Life Sciences are currently recruiting a Tech Transfer Lead, Drug Substance on behalf of our Multinational Biopharmaceutical Client based in Dublin on an initial 12-Month contract with potential to extend. Hybrid Position 3 days onsite.

Position Summary

The Tech Transfer Lead, Drug Substance, 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. This role with the MS&T team ensures robust technical transfer, process understanding, and operational readiness for clinical and commercial production of biologics. The position serves as a key cross-functional interface among Process Development, Manufacturing, Quality, Analytical, Supply Chain, MSAT, Regulatory, and CDMOs to deliver successful, compliant, and timely transfers.

Key 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 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 Qualifications

• 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

Preferred Qualifications

• Master’s degree or PhD in a relevant discipline
• Experience with monoclonal antibodies, recombinant proteins, or other biologic modalities
• Experience with external manufacturing partners, CMOs, or CDMOs
• Familiarity with process characterization, scale-down models, and comparability assessments
• Experience supporting clinical and/or commercial tech transfers
• Project management experience or certification

People are our business worldwide

Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.