中试研究员岗位职责

1、中试研究员岗位职责 中试研究室-研究员 绿谷制药 上海绿谷制药有限公司,绿谷制药,绿谷制药上海,绿谷 岗位职责: 1.制剂工艺的筛选、制定,开展和完成实验工作; 2.能独立完成制剂工艺进行中试扩大和生产; 3. 提交完成规范的研究报告及数据整理; 4.为新药注册提供相应部分的资料和数据报告; 5.生产制剂现场核查和生产现场核查的工作。 任职要求: 1.中药学、天然药化、中药制药、制药工程及相关专业; 2.能熟练掌握中药提取、分开、精制及制剂技术,同时具有一定药物分析实验基础; 3.能独立系统进行研究方案制定和研究报告撰写; 4.在校期间有中药新药研发经历。 5.英语六级 6.office熟练应

2、用 中试上游生产经理工作职责与职位要求 职位描述： 工作职责: 1. 负责抗体药物的细胞培养平台工艺的优化，包括细胞代谢的改善、抗体产量与质量的提升等。 2. 负责新技术、新工艺的开发应用及转移工作，包括atf灌流培养及高通量反应器的应用等。 3. 撰写细胞培养工艺相关sop、bpr，支持临床前200 l反应器规模生产与现场核查。 4. 为临床i，ii，iii期gmp生产提供技术转移及技术支持。 5. 撰写新药申报相关资料，包括国外申报相关的英文资料。 6. 协助进行工艺表征研究及工艺验证研究。 7. 对本部门员工进行技术培训并发展下级员工。 技能要求: 1. 硕士及博士学历，生物化工、制药工

3、程等相关专业。有3年以上工作经验者优先合计。 2. 熟悉生物反应器原理、发酵工程、细胞代谢、蛋白表达等理论知识。实验动手能力强并有优良的实验习惯，有较强的总结及分析能力并能解决工艺开发过程中碰到的复杂问题。 3. 关注抗体领域相关的新工艺、新技术，有灌流培养工艺开发atf、培养基开发、细胞株构建经验者优先录取。 4. 拥有工艺表征研究process characterization和工艺验证process validation的经验者优先录取。 5. 了解药品申报及管理法规，有项目管理经验，常常进行跨部门协作经验者优先录取。 6. 英语6级以上，专业英语写作能力特别者优先录取。 process

4、 technology engineer-pilot / 工艺/生产工程师-中试车间工作职责与职位要求 职位描述： job description summary: this position has responsibility for ensure a safe and profitable routing operations and maintenance for pilot unit in momentive performance material based in nantong, jiangsu providence. the process engineer is respo

5、nsible for the safety of the pilot unit routine operation and supporting/leading the pilot trial of new product scale up and process optimization, and leading all aspects of pilot facility maintenance, production monitoring et.al. the position will be in the process technology team located at the mo

6、mentive performance nantong company in nantong, jiangsu province, and the candidate will be reported to the china process technology manager based in shanghai china technology center specific responsibilities: follow the government and company ehs regulation and procedure to make sure all process an

7、d related activities comply with ehs standard and requirements. responsible for operation safety and environmental protection in pilot unit. support the process engineer for the scale up the new products in the pilot unit and the optimization study of the existing process. optimize/improve the exist

8、ing product process to reduce the product cost and improve productivity by working with continuous improvement team and process technology engineer. establish, update, and maintain production procedures, maintenance procedures, process/product control, and test data. collaborate with the site ehs to

9、 implement psm, such as moc, pha, pssr, hop, etc. related activities for the pilot unit. be responsible for his/her own safety and the safety of others who worked in the pilot unit. sign the work permit to the vendors who are working in the pilot unit area, and give the company ehs safety training f

10、or the internal and external resources working in the pilot unit. maintain the normal operation of equipment and instrumentation in the pilot unit and raw material of on-site management. conduct training for operates, new hires, contractors. lead and assist in the development and sustainability of 5

11、s in the unit. attend the daily shift-exchange meeting in the morning. required education and professional qualifications: bachelor or above in chemical engineering or relevant major. at least 3 years working experiences in process engineering, operation or relevant areas. good knowledge of the chem

12、ical engineering processes, like batch reaction, stripping, distillation et.al good understanding the fundamental principles in chemical processes good understanding of the process safety management and quality management system six-sigma, lean six-sigma, 5s experience are preferred. knowledge of instrument, electric domain. (dcs, pha,