Principal Manager, CMC External Manufacturing
Core
Manage DS/DP cGMP manufacturing and technical oversight at CRO/CDMO partners, ensuring compliance with quality, finance, ethics, and regulatory standards while supporting CMC supply chain planning.
Role type
Principal Manager, CMC External Manufacturing (Individual Contributor)
Builds
External manufacturing supply chain for pre-clinical and clinical stage small molecule or natural products
Domain
Pharmaceutical manufacturing / Chemistry
Required skills
cGMP manufacturing oversight, supplier review and audit, regulatory filing support, reaction optimization, scale-up protocol development, research project management, scientific presentation, publication authoring
Preferred skills
None stated
Technologies
None stated
Responsibilities
Manage external budget for CRO/CDMO operations, conduct site visits for diligence and audits, stay updated on pipeline needs for supply chain planning, prepare written and oral presentations to stakeholders, support reaction optimization and scale-up protocols, author and deliver publications to the scientific community
Seniority
Principal, hands-on IC