职位描述

WuXi XDC Cayman Inc. is a leading global CRDMO focused on antibody drug conjugates (ADC) and the broader bioconjugate market. It provides end-to-end contract research, development and manufacturing services for bioconjugates, including ADCs. Its services cover antibody intermediates and other biologics intermediates, chemical payloads and linkers, as well as bioconjugate drug substances and drug products. 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 December 2023, 143 on-going integrated projects are under development at WuXi XDC, including 59 post-IND bioconjugate projects, among which 21 projects are in phase II/III. Our XDC Analytical Sciences Department (XAS) now has open positions for Principal Scientist and Assistant Director for physicochemical analysis. We sincerely look forward to enthusiastic candidates willing to engage in ADC or bioconjugate analysis. Responsibilities: 1.Lead the analytical activities in CMC projects as function leader or function sponsor of Analytical Sciences. Coordinate with internal experts and other CMC functional areas to design tailored studies to meet regulatory standards and project objectives. Closely monitor the project with continuous scientific and technical support. Proactively identify potential issues and provide constructive suggestions timely. Prepare the analytical sections of filing dossiers to support regulatory submission including INDs and BLAs. 2.Engage directly with domestic and international ******s to convey analytical progress and resolve project-related technical challenges. 3.Cultivate talent and foster continuous improvements in physicochemical analysis and project management practices. 4.Laboratory management, including compliance, EHS, 5S, and instrumentation. Qualifications: 1.Ph.D. or M.S. in biochemistry, protein science, analytical chemistry, or related discipline, with specialized training in HPLC/UPLC, CE/iCIEF, or MS techniques. 2.Proficient understanding of HPLC/CE/MS principles and technologies, and hands-on experience in operation, maintenance and troubleshooting of HPLC/CE/MS. 3.Demonstrated expertise in physicochemical analysis of proteins and bioconjugates. 4.Working experience as function leader or function sponsor for CMC projects. 5.Strong team player with exceptional interpersonal, communication and presentation abilities, both written and verbal. 6.Proven track record as a proactive, independent researcher with advanced problem-solving skills and multitasking abilities. 7.Proficient in English communication, including reading, listening, writing, and speaking. Personal Growth/Career Development 1.Embrace a multi-level, diversified talent training and development system of WuXi XDC, comprehensively developing general skills, technical capabilities and leadership. 2.Gain extensive technical experience for biopharmaceutical analysis through WuXi XDC’ global technology platform. 3.Accumulate abundant CMC project experiences in a few years, not only in bioconjugates analysis, but also in process development, 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: 药物分析/药品检验

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

相关职位 更多

    求职技巧 更多