Director, Biologics Analytical
Core
Leading a global team to develop and validate analytical methods and control strategies for biologics (mAbs, ADCs, gene therapies) from clinical development through commercial manufacturing.
Role type
Director, Biologics Analytical
Builds
Analytical methods, validation strategies, and regulatory filing packages for biologics pipeline.
Domain
Biopharmaceuticals / Biologics / CMC
Required skills
Strategic leadership, analytical method development and validation, regulatory interactions (NDA/BLA), technology transfer, risk management (QbD), cross-functional collaboration, talent development, compliance management.
Preferred skills
Experience with modernization of manufacturing and quality controls, new technology evaluation, matrix team management.
Technologies
None explicitly listed beyond general analytical technologies.
Responsibilities
Provide strategic guidance and talent development for analytical scientists; define analytical strategies for new modalities; lead development, validation, and transfer of analytical methods; manage regulatory agency interactions and filing packages; solve complex technical issues in the regulatory landscape; balance resources for pipeline projects; foster scientific excellence and staff development; drive technical innovations; collaborate with R&D and Operations; identify external collaborations; ensure EHS compliance.
Seniority
Director, strategic leadership & hands-on technical oversight