职位描述

WuXi XDC, a joint venture between WuXi Biologics and WuXi STA, provides end-to-end contract research, development and manufacturing of bioconjugates, including antibody drug conjugates (ADCs). The company’s services cover antibodies and other biologics, chemical payloads and linkers, as well as bioconjugated drug substance and drug product. WuXi XDC has been successful in bringing multiple ADC projects to the Investigational New Drug (IND) filing stage in 15 months or less, nearly cutting in half the traditional development timeline. As of June 30, 2024, WuXi XDC is supporting 164 integrated ****** projects, including 20+ in late-phase stage. WGQ site is important part of WuXi XDC’s rapid global expansion, located at in Pudong New Area, Shanghai City. It includes XDC's early research, process development, analytical science and other departments. Our Bio-conjugation Process Development Department in WGQ site now has open positions for Senior Scientists (Bio-conjugation Process Development). We sincerely look forward to enthusiastic candidates willing to engage in conjugation process development. Responsibilities: 1.Develop conjugation and purification process for projects (plan, design and execute experiments) with state-of-art methods (e.g. OFAT, DoE), instruments (e.g. Reactors, AKTA, HPLC), and softwares (e.g. JMP, Minitab). 2.Draft and review batch record, technology transfer protocols, conjugation process development reports, and other documents. 3.Train and lead junior scientists to conduct daily experiments, assessment, transfer and troubleshooting. 4.Manage a group of junior scientists to efficiently complete experiments and documents to ensure on time delivery. 5.Laboratory management, including EHS, 5S and instrumentation. 6.Participate in CMC projects for biologics as Conjugation Function Leader. Coordinate with sponsors and internal expertise to design appropriate studies to meet regulatory requirements and project’s needs. Closely monitor the project with continuous scientific and technical support. Proactively identify potential issue and provide constructive suggestions timely. Prepare the conjugation sections of filing dossiers to support regulatory submission including INDs and BLAs. 7.Directly communicate with domestic and international ******s to report conjugation progress and solve technical issue of projects. Qualifications: 1.Ph.D. in chemical engineering, biochemistry, protein science, organic chemistry or a related discipline with training in conjugation process development or experience in ADC related projects. 2.Solid knowledge on the conjugation and purification theories and technologies, and hands-on experience in operating, maintaining and troubleshooting of related instruments, e.g. AKTA, HPLC, Reactors. 3.Experienced with conjugation process and purification skills and knowledge about antibody/biologics analysis is highly preferred. 4.Good team player with excellent interpersonal, communication and presentation skills (both written and verbal). 5.Independent researcher; strong problem solving and troubleshooting capabilities; proactive and self-motivated; good at multi-tasking. 6.Good English communication skills, including reading, listening, writing, and speaking Personal Growth/Career Development 1.Embrace a multi-level, diversified talent training and development system of WuXi Biologics/XDC’s, comprehensively developing general skills, technical capabilities and leadership. 2.Gain extensive technical experience for biopharmaceutical process development and analysis through WuXi Biologics/XDC’s global technology platform. 3.Accumulate abundant CMC project experiences in a few years, not only in process development, but also in protein analysis, manufacturing and regulation submissions. 4.Have chance to learn, work and grow with WuXi XDC in long-term developm********************

其他要求

招聘人数: 1
职能类别:

公司介绍

上海药明生物技术有限公司是上海药明康德新药开发有限公司的全资子公司,由原来的生物制药和生物工艺部,生物新药发现部独立出来成立了一家专门做生物制药的公司,这两个部门于2011年成立,于2015-5-1号独立出来组建新公司,是全球领先的制药、生物技术以及医疗器械研发开放式能力和技术平台公司,在上海和无锡均有运营实体。作为一家以研究为首任,以客户为中心的公司,药明生物向全球制药公司、生物技术公司以及医疗器械公司提供一系列全方位的实验室研发、研究生产服务,服务范围贯穿从药物发现到推向市场的全过程。药明生物的服务旨在通过高性价比、高效率的研发服务帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。 公司官网:http://www.wuxiapptec.com.cn 地址:中国上海外高桥保税区富特中路288号 查看地图发送到手机 邮政编码:200131

企业信息

  • 名称:上海药明生物技术有限公司
  • 行业:制药.生物
  • 性质: 中外合营(合资/合作)
  • 规模: 500-999人

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