發(fā)布時(shí)間:
2022
-
11
-
24
點(diǎn)擊次數(shù):
0
所屬職位:
工藝開發(fā)和CMC策略執(zhí)行總監(jiān)
所屬公司:
信達(dá)生物制藥(蘇州)有限公司
個(gè)人簡介:
Dr. Sun Chau Siu is currently Head of Process Development and CMC Strategy at Innovent Biologics. He has broad responsibilities in overseeing cell line development, process design and characterization, clinical manufacturing, and building a global CMC platform. Dr. Siu has over 20 years of international experience in the biopharmaceutical industry, with rich knowledge in GMP manufacturing, validation, MSAT, tech transfer, regulatory, CMC development, and process development. Before Innovent, he had worked at Genentech (USA). His professional experience also includes Roche (Singapore), Pfizer (UK), and Sanofi Pasteur (Canada). Among his experience, he played critical roles in the start-up of two biologics facilities, led multiple process tech transfers, successfully obtained health authority application approvals, and supported numerous health authority GMP/PAI/PLI inspections.Dr. Siu has a Ph.D. and MSc in Biochemical Engineering from University College London, UK, and a BSc (Hons) in Biochemistry and Chemistry from The University of British Columbia, Canada. He also obtained an executive MBA from Rutgers University, USA, and is a certified Project Management Professional (PMP).蕭新洲博士現(xiàn)任信達(dá)生物工藝開發(fā)部和CMC策略部執(zhí)行總監(jiān)。統(tǒng)管細(xì)胞株開發(fā)、上下游工藝開發(fā)和表征、臨床樣品生產(chǎn)和全球化的CMC平臺構(gòu)建。蕭博士在生物制藥行業(yè)擁有20余年的國際化從業(yè)經(jīng)驗(yàn),從業(yè)內(nèi)容涉及GMP生產(chǎn)、MSAT、注冊、CMC平臺建設(shè)和工藝開發(fā)。在加盟信達(dá)生物之前,他曾在Genentech (美國) 工作。此外還曾在羅氏 (新加坡) 、輝瑞 (英國) 和賽諾菲 (加拿大)工作過。他曾作為關(guān)鍵成員參與了兩個(gè)生物藥生產(chǎn)廠房的建設(shè),領(lǐng)導(dǎo)多個(gè)項(xiàng)目的工藝技術(shù)轉(zhuǎn)移,成功獲得監(jiān)管機(jī)構(gòu)的批準(zhǔn),并支持了大量的GMP/PAI/PLI審計(jì)活動。蕭博士擁有英國倫敦大學(xué)的生化工程博士學(xué)位和碩士學(xué)位,以及加拿大不列顛哥倫比亞大學(xué)的生物化學(xué)和化學(xué)學(xué)士學(xué)位。并獲得了美國羅格斯大學(xué)的工商管理碩士學(xué)位,以及項(xiàng)目管理專業(yè)人員 (PMP)認(rèn)證。