职位描述

Responsibility: 1.Oversee the development and implementation of HPLC/UPLC based methods in support of protein, mRNA product analysis, including method development, qualification/validation, troubleshooting, transfer to QC lab and collaboration with partner organizations. 2.Demonstrate strong technical capabilities in multiple analytical techniques 3.Lead and manage a small group of junior scientists. Supervise/mentor junior group members on daily laboratory work, experimental design, data interpretation and troubleshooting. Train and manage new group members on basic analytical lab skills and company compliance. 4.Proactively communicate and collaborate with cross-functional team members in technique, project goals and results discussion. 5.Draft and review of relevant CMC sections that support regulatory filings including INDs and BLAs. 6.Draft method related documents: Draft analytical method procedure, method development report, method qualification protocol and report, method transfer protocol, etc. 7.Maintain necessary documentation in accordance with company SOPs and GMP guidelines Qualifications: 1.Ph.D. or M.S. in analytical chemistry, biochemistry or related scientific discipline, 0-5 years (Ph.D) or 4-8 years (M.S) relevant experience is required. 2.Extensive hands-on experiences in HPLC/UPLC technologies, including industrial experiences in the development and validation of HPLC and LC-MS method for CMC supporting. 3.Experience in biochemical and physicochemical characterization of therapeutics protein or other biological product portfolio. 4.Proven technical writing skills demonstrated by peer-reviewed publications in professional journals. 5.Excellent communication skills (both verbal and written) and interpersonal skills. Fluent in English and Chinese. Self-motivated and organized. 6.In-depth knowledge of GMPs and experience in interacting with health authorities (FDA, EMA, CED etc.) are advantageous. 7.Experiences in analytical method development, validation and transfer for complex biomolecules (fusion protein, ADC, LNP) or late-stage biopharmaceutical projects are prefer********************

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

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