Drug Substance Tech Transfer Lead
Core
Lead post-approval drug substance technology transfers and new product introduction (NPI) activities across a diverse biologics portfolio to enable robust commercial manufacturing.
Role type
Senior IC Biologics Technology Transfer Lead
Builds
Reliable commercial manufacturing supply for biologics, including antibody-drug conjugates (ADCs)
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing scale-up and transfer)
Required skills
Biologics drug substance manufacturing, CMC, upstream/downstream/conjugation processes, post-approval transfer execution, NPI transfer support, site capability assessment, GMP operations, matrix organization leadership, risk management
Preferred skills
ADC transfer experience, digital technology transfer tools, Lean practices
Technologies
Digital technology transfer tools
Responsibilities
Lead post-approval drug substance technology transfers across internal and external sites; Deliver against Global CMC requirements and represent Operations needs in transfer strategies; Support NPI technology transfers for scalable commercial manufacturing; Assess site capabilities for process transfer and lifecycle changes; Partner with Manufacturing, Quality, Regulatory, and external partners; Embed GMP and inspection-readiness expectations; Drive standardization and continuous improvement across the transfer network.
Seniority
Senior, hands-on IC