Teams at LeonaBio

Lead QA oversight for outsourced cGMP clinical drug product manufacturing, batch record and deviation review, product disposition, CAPA and change control management, audits (internal and supplier), documentation, training oversight, metrics reporting, and support for regulatory inspections and computer system validation.

Lead technical and strategic analytical development for small molecule drug substance and drug product programs. Oversee method development, validation, transfer, specifications, vendor management (CROs/CDMOs), regulatory authorship for global submissions, lifecycle/change control, data integrity and quality investigations, and cross-functional alignment to support development milestones and commercial readiness.

Lead and execute in vitro and ex vivo oncology studies to evaluate therapeutic activity, mechanisms of action, resistance biology, and pathway modulation. Design, optimize, and troubleshoot cell- and molecular-biology assays, analyze complex datasets, and translate preclinical findings into development strategy, contributing to reports, presentations, publications, and patent filings.