Jobs 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.

Design and execute in vitro and ex vivo oncology studies; perform cell-based, molecular, and biochemical assays (Western blot, qPCR, ELISA, immunofluorescence); maintain mammalian cell lines; analyze and summarize data, maintain ELNs and SOPs; conduct literature reviews and communicate results to support preclinical oncology drug development.

Lead and execute in vitro and ex vivo oncology studies to evaluate drug activity, mechanisms of action, and resistance. Design, optimize, and run cell-based and immune-relevant assays, analyze complex datasets, and generate actionable insights to inform translational and clinical development. Contribute to reports, publications, patents, and program strategy while managing multiple projects in a fast-paced research environment.

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.