CMC Mgr. or Assistant Director 上海

月薪： 1-1.7万/月

该公司所有职位
  • 3-4年经验
  • 本科
  • 招若干人
  • 01-02 发布
  • 五险一金
  • 免费班车
  • 餐饮补贴
  • 绩效奖金
  • 定期体检

职位描述

1.Work closely with technical team members, clients and BD/BO to ensure the proposals generated for API, Drug Product and Analytical development projects meet regulatory requirement for CMC development in new drug application (such as IND/IMPD) with both domestic and international regulatory agents.2.Create and maintain detailed CMC project plans to ensure clarity of deliverables and timing.3.Answer the CMC related questions from client and internal teams.4.Coordinate meeting logistics including scheduling the meetings, sending out the agendas, writing and distributing minutes, tracking goals and action items, collecting meeting materials from line functions and distributing them to the team before the meeting.5.Assist the preparation of the responses to questions from CFDA /FDA and client regards to the work conducted in STA.6.Train the functional teams on the regulatory knowledge and requirement for CMC filing.任职要求：1. Education: BS, MS or PhD2. Major: Pharmaceutical Sciences, Chemistry or related majors3. Language: Proficient in English both written and spoken4. Work Experience: BS over 10 years’ experience, MS over 7 years’ experience and 5 years’ experience in project management is must.5. Skilled in CMC development and projects management experience6. Best knowledge of policy and regulations with new drug declaration of FDA\CFDA and European Union, especially for CMC R&D (API, Formulation and quality), best knowledge of CMC responsibilities on CTD declaration documents.7. Skilled on MS Project, Excel, PowerPoint, Word.8. Excellent on expression and communication, team work spirit and good planner.9. Focus on detail and be result driven, be a good leader. 职能类别： 生物工程/生物制药

联系方式

外高桥保税区德林路90号

公司信息

合全（sta）是药明康德全资子公司，其中包括：上海合全药物研发有限公司( 原药明康德工艺研发部，上海外高桥)，合全药物公司是sta 专门从事工艺合成路线研发及放大实验的研发团队；合全药业金山公司和常州公司是sta 提供符合cgmp 标准的中式放大及商业化生产的基地。shanghai syntheall pharmaceutical co., ltd. is a wholly-owned subsidiaries of wuxi app tec, including:sta r&d is professional in route selection and process scaled up r&d;sta jinshan and changzhou are the pilot plants and commercial production base under cgmp.sta 公司愿景 sta vision：改变创新药api 的工艺研发和生产模式，加快新药研发速度，降低新药成本，造福人类健康。transform how industry develops and manufactures apis, shorten the time and lower the cost of new drug developments, improve the quality of life.sta 公司使命 sta mission：不断创新、不断完善创新药api 的工艺研发以及研发和商业化生产的一体化平台，为全球新药研发机构提供最优质最高效的api 工艺研发和生产一体化服务和***解决方案。constantly enhance the capabilities of our fully-integrated api development and manufacturing platform from preclinical batches to commercial supplies, provide highly efficient and cost-effective solutions to our partners worldwide.

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企业入驻日期： 2017-11-09

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