發(fā)布時(shí)間:
2021
-
04
-
07
點(diǎn)擊次數(shù):
0
所屬職位:
副總經(jīng)理(生物制藥)
所屬公司:
齊魯生物制藥有限公司
個(gè)人簡(jiǎn)介:
劉丁目前擔(dān)任齊魯生物制藥有限公司副總經(jīng)理,負(fù)責(zé)生物制藥生產(chǎn)工藝技術(shù)和大規(guī)模廠房設(shè)計(jì)建設(shè)。 她擁有20多年生物制藥工業(yè)界全方位經(jīng)驗(yàn),從早期基因克隆篩選,成藥性研究,與CMC工藝開(kāi)發(fā)驗(yàn)證,技術(shù)轉(zhuǎn)移,到廠房設(shè)計(jì),工藝自動(dòng)化,精益運(yùn)營(yíng),GMP合規(guī)性,和大規(guī)模商業(yè)化生產(chǎn)。她作為CMC/項(xiàng)目負(fù)責(zé)人參與了多個(gè)創(chuàng)新抗體藥物與生物類(lèi)似藥的成功上市。 劉丁曾在美國(guó)GSK/HGS工作超過(guò)18年,具有多年2萬(wàn)升罐大規(guī)模生產(chǎn)的一線經(jīng)驗(yàn)。2014年回國(guó)后前后在藥明生物和百濟(jì)神州負(fù)責(zé)GMP生產(chǎn),工藝開(kāi)發(fā)與驗(yàn)證,技術(shù)轉(zhuǎn)移,生產(chǎn)科技,供應(yīng)鏈管理,以及各種生物藥廠房設(shè)計(jì)建設(shè)(不銹鋼,一次性與模塊化)。 Ding (Judie) Liu is currently Deputy General Manager of Qilu BioPharma responsible for BioPharma manufacturing process and technology. She has more than 20 years of broad experiences in biopharmaceutical industry, from early gene discovery and cloning, pre-clinical studies, to CMC process development and validation, tech transfer, to facility design, process automation, operation excellence, GMP compliance,and large scale commercial manufacturing. As the CMC/Project leader, she and her teams have successfully brought multiple innovated antibody drugs and biosimilar to the market. Judie has been working at GSK/HGS for over 18 years with many years hands-on experiences in 20000L-scale manufacturing. After returning to China, she has been worked at Wuxi Biologics and BeiGene in charge of GMP manufacturing, process development and validation, tech transfer, manufacturing science and technology, supply chain management, and biologics facility design (including stainless steel, single use, and modular).