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负责CMC团队的建立、完善和管理;制定原料药和制剂的开发策略和生产计划;指导解决新药工艺开发过程中的关键技术问题;负责管理外包研发生产服务供应商;负责与监管部门在CMC方面的沟通和交流;配合临床部门开展临床试验,提供药学方面的支持;配合注册部们完成各项目IND/NDA申报资料的撰写、审查,配合完成现场核查及注册申报。
An large organisation is looking for a facility management director to ensure all facilities operations and maintenance works and project/construction works are carried out in accordance with the established safety procedures at all times, including systems maintenance safety, site safety, workplace safety and hygiene safety
The R&D Quality Director will be responsible for overseeing all quality-related activities within the R&D department, ensuring compliance with GxP (Good Practice guidelines), supporting innovation, and promoting high standards of product quality and safety. This role is pivotal in establishing a robust Quality Management System (QMS) for R&D and ensuring adherence to Good Manufacturing Practice (GMP) and scientific practices.
1.Provide End to End regulatory expertise to innovation projects in China R&D.2.Ensuring compliance of raw materials and finished cosmetic products developed in line with chemical and cosmetic regulations in China and Asian countries.
The Enzyme R&D Director will oversee enzyme discovery, production technology, purification, and process scale-up to ensure the delivery of high-quality enzyme products that meet the company's strategic goals.