工作职责：
1.对日常生产的技术支持 Technical support to the daily production
- 关注日常生产中的工艺质量问题，对生产中出现的异常情况或偏差作因果分析 Pay a close attention to daily production, make root-cause analysis for the deviation of any technical issues arose in production.
- 必要时编写工艺改进试验方案并进行试验 When necessary, draft process optimization protocol and make trials.
- 参与对生产员工的工艺培训 Instruct or give technical training to production personnel.
2.对新产品注册的支持 Support the registration of new products.
- 负责完成注册样品的试制及稳定性考核 Responsible for the preparation of registration batches, including the preparation of registration samples, follow up of stability study and other activities related to the registration of LMP.
- 编写试验方案 Put forward trial protocol
- 具体进行试验，并做好试验记录 Conduct the trials and make records
- 完成注册样品的制备与包装 Complete the registration sample preparation and their packaging
3.新产品的投产工作 Industrialization of new products
- 协助完成新产品投产前的准备工作， 包括工艺参数的最终确定、技术文件的修订 Help to complete the preparatory work of new products, including the simulating trials , finalization of process parameters and the compiling of technical document.
- 参与前3批的试生产及其验验 Participate in the manufacturing of first 3 industrial batches and their validation
职位要求：
本科或以上学历 College degree or above on pharmacy or related
有工业药剂开发工作经验者优先Experience in industrial pharmaceutical development or related technical background are highly preferred
熟悉GMP以及药品注册等有关法规Familiar with GMP/ICH guidelines.
对客观事物发展的因果关系具备较强的分析能力 Good skills on cause & effect analysis
对科学研究的浓厚兴趣 Interest in scientific activity
积极主动、团队合作的工作精神Proactive and teamwork spirit
善于进行独立而有创造性的工作 Show ability to work independently & creatively
良好的英语读写能力及听说能力 Good English listening, speaking and writing skills.
