1、Provides strategic leadership, technical expertise, and specialized knowledge in analytical method development for release and stability testing of biological substance, raw materials, intermediates and drug product from human body fruid samples, such as serum, urine, tissues, etc.具备战略领导能力，专业技术和专业知识，能发出分析法的研制和稳定性测试提供分析方法，主要在生物学的内容，原材料，媒介和药物产品上，来自人体体液样本，比如血清，尿液，组织等2、Identifies analytical science capabilities and technology tools needed to enable analytical process development, QC testing, for new biological metablites analysis.识别分析技术能力和技术工具，需要有能力分析开发过程，质量检测，对新的生物学代谢物进行分析3、Applies scientifically-driven thinking to the development of scientifically sound, well understood, and robust analytical methods.应用科学的办法去开发，很好的理解能力和有效的分析方法4、Coordinates with other internal departments to review/approve qualification/validation of analytical methods.协调其他内部部门对分析方法给予回复/批准资格/验证5、Leads analytical method transfer, qualification and validation to commercial QC and as needed for contract laboratories.指引分析方法转让，资质证明和验证对商业质量控制，根据需求找实验室6、Review of raw data packages associated with release testing, stability testing, and other characterization testing of targeted biological samples.回顾原始数据包与发布测试，稳定性测试和其他鉴定测试相联系，测试生物样本7、Leads development of scientifically sound and data driven specifications and represents Analytical Development at the Specifications Committee.引导发展科学的发声和数据驱动规格和表现分析发展在规格委员会8、Oversees analytical and QC activities at CMOs and Contracting Testing Laboratories (CTOs), including the review and approval of test records, forms, methods, protocols and reports.监督分析和质量控制活动和签订测试实验室，包括检查和批准实验数据，表格，方法，协议和报告9、Prepares and delivers technical reports, documents, batch analyses, analytical methods, reference standard, etc. for regulatory submissions.为管理监督意见书准备和递交技术报告，文件，分批测试，分析方法，参考标准等10、Set up and perform experiments in the laboratory in support of analytical method development, and troubleshooting.在实验室建立和完成实验，对分析需求研制和排查给予支持11、Serves as point expert for areas of responsibility during regulatory inspections.在管理检查期间作为专家服务责任范围12、Keeps up to date with regulatory requirements including those of the CFDA and various international regulatory governmental bodies.关注最新的法规要求包括国家食品药品管理监督总局和多方面国际法规13、Provides support and contributes to other analytical and Quality Control activities as necessary.必要时提供帮助和促成其他分析和质量检测活动Qualifications:职位要求1、Degree in chemistry or other scientific discipline (PhD or Equivalent)化学专业或者其他科学学科专业（博士学位或同等学历）2、4 years or more in analytical and QC area在分析和质量检测领域有4年或以上的工作3、Experience in analytical method development/validation is required必须具有在分析方法的研制和验证的经验4、Experience with drug/device combination products is a plus优先考虑有药品或药械组合产品设备的经验5、Experience with analytical method development for proteins and peptide is preferred最好有对蛋白质和肽的分析方法研制的经验Experience经验:1、Hands-on experience with analytical method development and validation在分析方法研制和验证方面有实践经验2、Experience with managing internal and external analytical and QC labs有管理内部和外部分析法和质量检测标准的经验3、Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to quality testing of pharmaceutical products在《药品生产质量管理规范》上有广泛的工作知识，了解有关药品的质量检测的法律法规4、Ability to establish and maintain effective working relationships.有建立和持续有效工作关系的能力5、Outstanding problem solving abilities.出色的解决问题的能力6、Ability to recognize the potential of new technologies to meet analytical testing requirements.有辨认潜在的新技术的能力用来分析检测的需求。7、Detail-oriented, with good organizational and project management skills. Ability to effectively prioritize and deliver on tight timelines注重细节，有很好的组织和项目管理能力。有能力在有限的时间内有效安排事情的优先顺序。8、Must be a team-work player and be able to collaborating with external and internal colleagues.一定具有团队精神，能够与内部和外部的同事合作9、Good oral and written communications skills; proficient with MS Word, PowerPoint, Excel良好的口头和书写沟通技能；精通使用Word, PPT, Excel.职能类别：综合门诊/全科医生生物工程/生物制药关键字：功能医学检测精准医疗