Serve as formulation lead of new drug development projects and provide technical expertise on formulation and process development/optimization. Lead, plan and execute product transfer, PSB/PPQ/PAI/launch campaigns readiness.Interface with CDMOs, suppliers, and internal clients. Efficiently communicate with different functional stakeholders to align the work priority and the production timeline.Design and review experimental protocols independently or with CDMOs. Manage all GMP… Show more Serve as formulation lead of new drug development projects and provide technical expertise on formulation and process development/optimization. Lead, plan and execute product transfer, PSB/PPQ/PAI/launch campaigns readiness.Interface with CDMOs, suppliers, and internal clients. Efficiently communicate with different functional stakeholders to align the work priority and the production timeline.Design and review experimental protocols independently or with CDMOs. Manage all GMP manufacturing activities including clinical, registrational, and validation batches at CMO or internal sites.Write and edit pharmaceutical and formulation development report to be included in NDA CMC dossiers.Familiar with Gastroplus to conduct modeling simulation, as a instructive method and lead for FIH formulation develooment and formulatiin change or optimization during clinical phase. Show less

着重于创新型候选化合物的可开发性评价以及难溶性药物的制剂开发策略。涉及基本的物理化学性质表征，固体化学研究（晶型盐型筛选），以及不同给药途径的液体，半固体及纳米递药系统的开发。

参与不同仿制药项目，从立项，试验设计，中试放大到验证批生产的各个阶段，熟悉固体口服制剂的开发思路与流程。