职位描述

职位描述： Special Requirements: - This Biochemist II position is in the Technical Operations Department supporting the manufacture of immunoassay products for Atellica and ADVIA Centaur systems diagnostic products in China Siemens Healthineers. This position will be based in Shanghai but will have frequent interactions with the US Technical Operations group in Walpole, M- A. Specifically, this position will support the transfer of immunoassay products from the US to China facility, participating in equipment and instrument validation and product performance qualification, as well as preparing technical files required for regulatory submissions. Responsibilities also include Atellica and ADVIA Centaur Systems Immunoassay Products Manufacturing Support, maintaining necessary output to keep the China Immunoassay service position at an acceptable level. The position responsibilities will change and grow as the China Manufacturing project moves through different phases. . Scope of work: In addition to the specific responsibilities and duties previously listed, the position also requires that the employee work within a team environment to: - lead or participate in investigations relating to manufacturing issues; - coordinate and carry out investigations and implementation of corrective and preventive actions (CAPA); - create and participate in the design of experiments (DOE) to troubleshoot manufacturing issues; - coordinate and perform data analysis and write internal reports and other documentation; - prepare protocols and reports for feasibility, characterization, stability, verification and validation studies; - coordinate and perform Design and Process changes; - lead a team or directly investigate the performance of new and re-formulated assays or raw materials used in the manufacturing process. Typical Education: - BS in Medical Technology, Biology, Chemistry, Biochemistry, or Immunology Typical Job Related Experience: 6+ Years job related experience Specific skills: - The candidate must have a good understanding and knowledge of polyclonal and monoclonal antibodies and principles of immunodiagnostic technology, as well as experience with immunoassays, including automated immunoassay analyzers and/or ELISA and chemiluminescent technology. Candidate must have demonstrated ability to interpret data and to troubleshoot and resolve technical issues. Candidate must also possess excellent written and communicational skills, a strong work ethic, and the ability to work independently and to effectively prioritize and manage multiple assignments. Proficiency in Microsoft Office Applications and statistics software is also required Preferred Knowledge/Skills, Education, and Experience: - Advanced degree in Medical Technology, Biology, Chemistry, Biochemistry, or Immunology preferred. Previous product support and technical troubleshooting experience in a GMP/GLP industry setting preferred. Good verbal and written skills with Mandarin and English languages.提醒： 　　点击“西门子专属申请”，您将会进入西门子专属招聘系统，进入系统后您可以在页面右上方的下拉菜单，选择简体中文页面，并请遵循下面的规则设置您的系统密码。 　　密码设置规则：密码长度必须在8个字符以上，并且必须包含英文大写字母，小写字母和数字。例如：Ab123456 职能类别： 医药技术研发管理人员 化学分析测试员

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