Tech Transfer Lead, Drug Substance Biotech - 11 Month - Hybrid
Position Summary
The Tech Transfer Lead, Drug Substance Biotech, 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
