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 analytical development strategy and execution for small-molecule drug substance and product programs. Oversee method development, validation, transfer, specifications, vendor management (CROs/CDMOs), regulatory authorship for CMC/NDA submissions, quality investigations, lifecycle/change activities, and cross-functional analytical decision-making to support development and regulatory milestones.