Teams at Korro Bio, Inc.

Lead strategic and operational management of global clinical supply activities across development phases. Oversee supply planning, inventory, labeling, packaging, distribution, IRT/IXRS, vendor relationships, cold chain logistics, regulatory compliance, and QA collaboration to ensure timely, GMP-compliant delivery of investigational medicinal product to clinical sites worldwide.

Provide hands-on CMC quality oversight for CMOs and external vendors ensuring cGMP compliance across manufacturing, testing, batch release, audits, deviations/CAPAs, change control, and vendor qualification. Lead clinical lot disposition, audit programs, QTAs, inspection readiness, quality metrics, and support CMC regulatory submissions (INDs/IMPDs) for multi-regional clinical development.

Lead analytical strategy for synthetic oligonucleotide drug substance and product: develop, transfer, qualify/validate analytical methods (LC-UV, LC-MS, HRMS, UV-Vis), manage CMO/CRO analytical activities, support stability and impurity characterization, author regulatory documentation, and lead investigations/OOS resolution to support clinical and regulatory progress.