生物制药稳定性研究员Stability Scientist 上海

月薪： 6-8千/月

该公司所有职位
  • 2年经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： Key accountabilities:Technical Leadership in the stability study design of ADQC stability projects, from batch selection, stability indicating assay confirmation to time points design.Responsible of stability plan establishment and maintenance.On time delivery of the protocols and/or reports of ADQC stability studies and ensure the effectiveness of the protocol training.Creation of the effective and clear tracking chart and update template of stability study status, on-time tracking of stability study status and regular update of the study status proactively.Stability data analysis using statistical software together with the ALs to provide scientific rationales on the shelf-life definition and further internal release limit setting.Lead stability deviation investigation and support stability OOS investigation as the stability SME.Work with the team for continuous improvements.PERSONAL QUALIFICATIONEducation Background: Bachelor or above degree in Biochemistry, Biology, or related major.Professional training: optimal cGMP training, familiar with the stability study requirements in Pharmacopeia, ICH, and Health Authorities.Work Experience: 2 to 5 years of Biopharmaceutical Industry experience in stability study, familiar with Biologics production process and analytical assays, optimal cGMP experience.Skills: statistical data analysis (e.g., excel or minitab, or other statistical software), cross-functional cooperation, communication skills and on-time-oriented project management. Fluent Spoken and Written English. 职能类别： 生物工程/生物制药 关键字： 稳定性 数据分析 生物制药

联系方式

上海市外高桥保税区富特中路288号

公司信息

药明生物（WuXi Biologics）是香港上市公司（代码：2269），我们是全球领先的开放式、一体化生物制药能力和技术平台，旗下包括无锡药明康德生物技术股份有限公司、上海药明生物技术有限公司、苏州药明康德检测检验有限责任公司，并在美国和英国设有子公司。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务，帮助任何人、任何公司发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。目前，公司规模达到2300多人，有200多位拥有海外高等学位和工作经验的海归科学家，拥有丰富的欧美市场抗体开发、生产、质量控制、临床前研究和注册的经验，打造了世界一流的生物药研究、开发及生产团队。 更多信息，请登录公司官网：http://www.wuxibiologics.com.cn/

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