Job Description: Tech Transfer Lead, Drug Substance
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.
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, 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, 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 characterisation, scale‑down models, and comparability assessments
Experience supporting clinical and/or commercial tech transfers
Project management experience or certification
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