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SHDM Biochemist II

Job Description

Responsibilities:

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 communications with the US Technical Operations group in Walpole, MA. 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.

   技术运营部的Biochemist  II职位主要是支持中国西门子 Atellica 和 ADVIA Centaur系统上免疫产品的生产。该职位位于上海工厂,同时会与美国马萨诸塞波尔沃工厂的技术运营部保持沟通。该职位主要是为免疫产品从美国转移到中国工厂的生产提供技术支持,并参与仪器的验证和执行性能评估,并参与注册需要递交的技术文件的准备。职责包括Atellica 和 ADVIA Centaur系统上免疫产品的生产支持,保持必要的产出,使中国免疫测定服务处于可接受的水平。 随着中国制造项目的发展,该岗位的职责将发生变化和增长。

•In addition to the specific responsibilities and duties listed in position headline, the position also requires that the employee work within a team environment to:  

•prepare protocols and reports for feasibility, characterization, stability, verification and validation studies; 

为可行性分析,性能评估,稳定性评估,验证和确认研究完成实验方案和实验报告。

•support local products registration process;

支持本土产品注册流程;

•lead or participate in investigations relating to manufacturing issues; 

领导或参与试剂生产中的问题研究;

•create and participate in the design of experiments (DOE) to troubleshoot manufacturing issues; 

创建和参与试剂生产中问题解决中的实验设计;

•coordinate and perform data analysis and write internal reports and other documentation;

协调和执行数据分析并撰写报告或其他文件;

•coordinate and perform Design and Process changes; 

协调和执行设计变更和工艺变更;

•lead a team or directly investigate the performance of new and re-formulated assays or raw materials used in the manufacturing process.

领导一个团队或直接研究新的试剂产品或重新调整的试剂产品或者生产过程中原料更换导致的性能研究


Education and Experience:

•Previous experience with immunoassays, including automated immunoassay analyzers and/or ELISA and chemiluminescent technology. (BS +4 years, MS +2 years)

具备免疫产品的相关经验,包括全自动免疫产品或ELISA和其他化学发光产品。(本科4年以上,硕士两年以上)

•Previous product support and technical troubleshooting experience in a GMP/GLP industry setting preferred.

如具备在GMP/GLP环境下产品支持或技术问题解决经验者优先。

•BS in Medical Technology, Biology, Chemistry, Biochemistry, or Immunology.

医学技术、生物学、化学、生物化学或免疫学学士学位。



Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Manufacturing Ltd., Shanghai

Experience Level: Experienced Professional

Job Type: Full-time

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