The job holder ensures to meet / perform 该职务确保能达到或履行：

- 能够独立开展生物化学试验Able to independently perform biochemical experiments;

- 能够根据时间的安排，独立进行研发试验的时间计划并且撰写研发方案Able to independently plan experiments and write experiment plans;

- 能够独立进行研发试验结果分析并撰写研发试验报告Able to generate reports;

- 能够独立思考，在研发过程中解决基础的技术问题Able to do basic trouble shooting;

- 能够有秩序的管理实验室包括试剂耗材以及设备Able to manage lab operations under regulation.

- 具备免疫基本知识；Solid in immunology basic knowledge.

- 具备独立研究的能力，擅长理解和学习新技术和新方法。Independent research capability, good at understanding and learning new technology and method.

- 有化学发光或酶联免疫相关产品的开发经验；Experienced in CLIA or ELISA.
Main Tasks & Responsibilities主要工作职责:

- 根据开发计划，负责产品开发的完整过程；According to the development plan ,to response for the whole development details;

- 负责向生产部、质量部提供技术支持，负责生产环节的技术指导；Provide technical support to the production and quality department, provide the technical guidence to the production section.

- 负责撰写相关技术文档并配合完成临床及报批注册工作；Be responsible for the technical documentation and cooperate to fulfill with the clinical and approval certification .

- 主管分配的其他任务。Other task assigned by supervisor.

Education& Qualifications教育背景与专业资格:

- 生物、生物化学以及药学背景，硕士及以上学历Biology/Biochemistry/Medicine major, master degree and above;

- 有分子生物学试验经验，可以对临床样本进行前处理，对免疫平台，比如化学发光、酶联免疫等方法学有比较丰富的经验Experiences of molecular experiments, familiar with clinical sample treatment; fully experienced with immunoassays, for instance: CLIA or ELISA platform.

- 有体外诊断试剂研发经验，了解抗原抗体的设计、选择供应商等 Have Experiences in IVD reagest development, familiar with antibody design, supplier selection, and etc.

Experience工作经验:

- 3年或以上工作经验；3 years and above working experiences

- ***有在体外诊断试剂产业工作的经验，或者有第三方医学检验实验室工作经验Better have working experience in IVD industry or ICL；

- ***有高灵敏免疫平台的使用经验，包括MSD、SIMOA等。Better have experiences in Hyposensitive immunoassays, like MSD and SIMOA;

- ***有在ISO13485条规下工作的经验Prefer experiences of working under ISO13485 regulation

Language skills 语言能力

中文Mandarin

英文English

其他信息

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