Associate Director, Drug Substance Tech Transfer Lead
Core
Lead end-to-end drug substance technology transfers for biologics and Antibody-Drug Conjugates (ADCs) to ensure reliable commercial supply and scale-up.
Role type
Senior IC Associate Director, Biologics Tech Transfer
Builds
Robust, compliant, and efficient manufacturing processes for biologics and ADCs at commercial scale
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
CMC leadership, post-approval tech transfer, NPI transfer support, upstream/downstream/conjugation processes, site capability assessment, GMP operations, matrix leadership, risk management, digital tech transfer
Preferred skills
ADC conjugation experience, digital platform implementation, lifecycle change management, external partner representation
Technologies
Digital tech transfer platforms, data governance tools
Responsibilities
Lead post-approval drug substance tech transfers across internal and external sites; Represent manufacturing operations in cross-functional NPI planning; Conduct technical assessments and resolve issues for diverse biologic modalities; Evaluate site capabilities for process fit and compliance; Drive standardization and continuous improvement of transfer practices; Champion digital tools for visibility and execution efficiency
Seniority
Senior, hands-on IC with matrix leadership