Biopharmaceutical CMC, Regulatory, & Manufacturing Expertise
Senior-level leadership across biologics and small molecules—from development and regulatory strategy through technology transfer, validation, approval, launch, and commercial manufacturing.
R&D → Approval → Commercial | 40+ Tech Transfers | 100+ CMC Dossiers | Global Manufacturing
JC Bonner, PhD, RAC
Founder & Principal, The One When
Biologics Development & Manufacturing
Process development, scale-up, manufacturing science, validation, troubleshooting, lifecycle management, and commercialization across drug substance and drug product.
CMC & Regulatory Strategy
Integrating development, manufacturing, quality, and regulatory strategy to create robust CMC packages, resolve technical issues, and support successful filings, approvals, and inspections.
Technology Transfer & Commercialization
More than 40 technology transfers across biologics and small molecules, spanning development, scale-up, validation, PPQ, launch, and established commercial supply.
Small-Molecule Development & Manufacturing
Deep experience in API/drug substance and drug product development, process engineering, scale-up, continuous manufacturing, validation, and global manufacturing.