Director of Pharmaceutical Chemistry Department
Company: Zhejiang Zongheng Human Resources Co., Ltd.
- Location: North Rhine-Westphalia, Germany
- Seniority: Director
- Employment type: Full-time
- Posted: 14 days ago
- Offer language: English
Job description
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.
II. Core Job Responsibilities
Technical Strategy & Pipeline Planning
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.
API R&D Management
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.
End-to-End Formulation R&D Management
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.
Technology Transfer, Industrialization & Compliance
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.
Cross-functional Collaboration & Project Control
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.
