Senior Director, CMC Product Lead and Biologics Technology Transfer – Global Operations
Core
Lead complex Global CMC programs and Operations teams for biologics and advanced modalities, ensuring operational readiness, regulatory alignment, and reliable market supply from development through commercialization.
Role type
Senior Director, CMC Product Lead and Biologics Technology Transfer
Builds
Global CMC programs, biologics technology transfer networks, and scalable manufacturing operations
Domain
Biopharmaceuticals / Biologics / CMC / Global Operations
Required skills
Biologics leadership, Global CMC strategy, Technology transfer management, Organizational development, Matrix leadership, Regulatory knowledge (GMP/CMC), Process validation, Lifecycle management, Talent development, Digital transformation
Preferred skills
Advanced degree, Experience with complex modalities, Digital transformation in manufacturing, AI-enabled capabilities, Change leadership
Technologies
AI-enabled tools, Advanced analytics, Digital tools
Responsibilities
Lead Operations Global CMC teams for complex biologics programs; Define and drive integrated CMC strategies; Lead and develop the GTO Biologics Technology Transfer organization; Implement business processes for robust technology transfer; Partner with sites and functions to raise network maturity; Assess and reflect new regulatory requirements in practices.
Seniority
Senior Director, Strategic Leadership