
Director, Cell Culture Process Development

職位描述
This is a newly created position that will lead the cell culture process development (CCPD) group in Wuxi city.The group is being setup with the following main responsibilities:1. To lead tech transfer activities and provide on-site and on-floor cell culture support for the cGMP facility in Wuxi city;2. To develop & optimize cell culture processes for IND-enabling projects per China/US/EU regulatory requirements;3. To develop & optimize late-stage (Phase II/III) cell culture processes, including design and execution of process characterization and validation studies. Key aspects of the position include hiring/coaching/mentoring and managing junior staff members; technical oversight of study design, execution and results interpretation; interaction with manufacturing groups and development groups in Shanghai; and managing budgets etc.Qualifications:1. The candidate should have a PhD degree and at least 6 years industry experience, or MS degree and at least 10 years industry experience.2. He/she must have hands-on mammalian cell culture process development experience for protein therapeutics (preferably monoclonal antibodies), and have strong expertise in process optimization, scale-up and technology transfer.3. Experience with medium optimization, DoE studies, regulatory submission to the FDA/EMEA and personnel management is a plus.The position is based in Wuxi city.
企業(yè)簡介
十一年前,藥明康德的創(chuàng)始人李革博士肩負(fù)著變革新藥研發(fā)、造福人類健康的人生理想,創(chuàng)立了藥明康德;如今,藥明康德已成為在中美兩國擁有7000余名員工、中國首屈一指、全球領(lǐng)先的醫(yī)藥研發(fā)外包服務(wù)供應(yīng)商,在全球九大城市擁有運(yùn)營實(shí)體,客戶囊括全球制藥巨頭前二十。作為國內(nèi)醫(yī)藥研發(fā)服務(wù)的領(lǐng)頭羊,藥明康德無疑是卓越的醫(yī)藥研發(fā)平臺(tái),并繼續(xù)致力于打造創(chuàng)新型的、全方位一體化的研發(fā)服務(wù)平臺(tái)。
[展開全文] [收縮全文]江蘇相關(guān)職位: 無夜班護(hù)士 婦科醫(yī)生 學(xué)術(shù)推廣 電商運(yùn)營 藥品采購 駐店執(zhí)業(yè)藥師
熱門區(qū)域招聘: 重慶 北京 上海 浙江 江蘇 廣東 山東 湖南 安徽 河北
江蘇招聘企業(yè): 吉林萬通藥業(yè)集團(tuán)藥品經(jīng)銷有限公司 江蘇吉貝爾藥業(yè)有限公司 魚躍醫(yī)療 徐州新沂市鐘吾醫(yī)院 麗珠醫(yī)藥集團(tuán)股份有限公司 無錫道生中醫(yī)文化發(fā)展有限公司 廣東眾生藥業(yè)股份有限公司蘇北辦事處 江蘇大豐同仁醫(yī)院 江蘇南中醫(yī)豐盛健康城有限公司 江蘇南京溧水區(qū)中醫(yī)院
職位發(fā)布日期: 2015-01-21

