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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。
Manage well of mainland China's business, Drive business growth.Transfer business from countermanded to standardized service mode
Responsible for furniture product development/engineering/quality management for the companyLead the PD/engineering/quality/production team
Responsible for managing R&D practices, establishing technical standards and systems, and overseeing project management within the engineering department.Play a pivotal role in driving innovation, developing new technologies, and ensuring the successful execution of engineering projects from concept to implementation.
The SPAD R&D Director will lead and manage the Single-Photon Avalanche Diode design team, driving the development and implementation of SPAD technology in the products.
As the expert in III-V laser device, you would be responsible for driving the R&D activity and ensuring on-time deliver of the product.