Director of Pharmaceutical Chemistry Department

Overall responsibility for the technical strategy, project management, technical troubleshooting, process development, technology transfer and regulatory technical support of the Group’s integrated API + formulation R&D pipeline; oversee API synthesis/fermentation/polymorph studies, formulation formulation and process development (solid dosage forms, injectables, etc.), pilot scale-up and process validation to support generic drug consistency evaluation, modified new drug development and overseas DMF/CEP filings of APIs.

Lead the technical team to realize industrialization of products in compliance with domestic and international GMP requirements.

Lead the project initiation evaluation of new API and formulation products in alignment with corporate strategy, conduct market, patent and technical feasibility assessment; formulate medium- and long-term technical roadmaps, develop high-barrier generics, modified formulations and specialty APIs, prioritize pipeline projects, manage budget and resource planning, and deliver annual R&D targets and KPIs.

Oversee chemical synthesis/fermentation process development, impurity research, polymorph and salt screening, process optimization of APIs, covering lab-scale → pilot → commercial scale-up; resolve critical technical challenges in process stability, yield and impurity control; lead the preparation of DMF and CEP dossiers to support domestic and international regulatory inspections.

Oversee formulation development, process research, stability studies, dissolution/in-vivo evaluation for solid dosage forms, injectables and other dosage forms; lead generic consistency evaluation and modified new drug development; review full R&D protocols, CTD registration dossiers, process validation protocols and technology transfer documents to ensure smooth registration and filing.

Drive technology transfer of API and formulation R&D achievements to manufacturing workshops, organize process validation; establish GMP system on the R&D side and ensure data integrity; take charge of on-site inspections by NMPA, FDA and EMA; lead investigations into deviations, OOS/OOT results and quality risks, and implement CAPA.

Coordinate with regulatory affairs, QA/QC, production and supply chain teams to control project milestones, costs and risks; organize project reviews, identify major technical risks and develop contingency plans; liaise with external CROs and technical collaboration projects.