Teams at LeonaBio

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.

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.

Execute hands-on preclinical experiments for oncology and neurology programs, maintain mammalian cell cultures, run cell-based/molecular assays (viability, western blot, ELISA, qPCR, IF), manage samples and inventory, document data in electronic lab notebooks, support assay optimization, and maintain lab equipment and organization.