工作目标 objective
负责实施并完成新产品项目的开发和新产品项目向生产质量体系的移交。
Implement and accomplish NDP (New Product Development) projects development and transfer these new projects to production and quality system.
工作主要职责 responsibility (列出5-7项)
? 负责每年度新产品开发项目的实施：负责处方前研究、处方筛选、工艺路线设计及优化；完成IND批次的制备；协调NDA批次和临床样品的制备。
Be responsible for implementation of annual NDP projects: take charge of preformulation study, formula screen, process design and optimization; complete IND batch production; coordinate preparation of NDA batch and clinical samples.
? 负责完成新产品相关注册资料药学部分的整理起草，协助完成IND/NDA的申报。
Be responsible for the drafting of pharmaceutical section within application dossier for new product, assist IND/NDA submission.
? 负责完成每年度新产品项目的技术移交：负责完成新产品生产技术资料的起草；完成技术移交、工艺放大、工艺相关验证。
Be responsible for the technique transfer of annual NPD projects: take charge of technique an pro-duction documents written, complete technique transfer, scale up and process validation.
? 协助研发中心制剂实验室设备仪器的日常管理、定期校验和维护。
Assist daily management, regular calibration and maintenance of pharmaceutics equipments in R&D Centre.
? 协助研发中心科学文献检索，专利申报和信息系统的管理和研发资料文件系统维护。
Assist Scientific Literature search, Patent registration, information system management and R&D document system maintenance in R&D Centre.
? 协助研发经理保证J&J EHS的相关政策规定在相应工作区域正确有效的实施。
Assist R&D manager to ensure J&J EHS policies are properly and effectively implemented in appropriate work areas.