工作职责:
1.参与和主导微生物鉴定药敏相关试剂的设计、优化和验证工作；
2.根据研发部工作计划完成试剂研发从复现、优化、测试、生产工艺开发、中试、转产、验证到注册报证，解决研发过程中的疑难问题；
3.负责体外诊断试剂的设计、开发、输出及相关文件撰写（包括工艺规程、技术要求、说明书、风险管理及注册文件的编写）；
4.对新产品的注册资料编制、申报等相关工作提供支持；
5.负责体外诊断试剂开发所需条件的准备、测试开发试验的执行，以及试剂研发团队的组建和实验室管理工作；
6.负责体外诊断试剂临床测试和新品上市技术支持工作；
7.参与到产品开发和上市的全生命周期各个环节，深入了解临床终端用户需求，熟悉产品开发流程和逻辑，并进行跨部门（包括仪器、软件和卡盒）合作，解决复杂疑难技术问题（如仪器、软件、卡盒和生化试剂集成开发等），不断提升产品竞争力。



Job Responsibilities:
1. Participate in and lead the design, optimization, and verification of reagents related to microbiological identification and drug sensitivity.
2. Complete the reagent R&D process from reproduction, optimization, testing, production process development, pilot production, transfer to production, verification to registration and licensing according to the R&D department's work plan, and solve difficult problems during the R&D process.
3. Be responsible for the design, development, output, and related document writing of in - vitro diagnostic reagents (including the preparation of process specifications, technical requirements, instructions, risk management, and registration documents).
4. Provide support for the compilation and declaration of registration materials for new products.
5. Be responsible for the preparation of conditions required for the development of in - vitro diagnostic reagents, the execution of test development experiments, as well as the establishment of the reagent R&D team and laboratory management.
6. Be responsible for the clinical testing of in - vitro diagnostic reagents and technical support for new product launches.
7. Participate in all aspects of the entire life cycle of product development and launch, deeply understand the needs of clinical end - users, be familiar with the product development process and logic, and conduct cross - departmental cooperation (including instruments, software, and cartridges) to solve complex and difficult technical problems (such as the integrated development of instruments, software, cartridges, and biochemical reagents), and continuously improve product competitiveness.
任职资格:
任职资格:
1.微生物学、生物化学或相关专业学位，博士学位优先。
2. 一年微生物学家工作经验；
3. 具备规划和执行实验方案的能力。
4. 对电子显微镜、电子设备、化学样品、染色剂以及称重设备有深入了解。
5. 在微生物技术、方法、设备及耗材方面技艺精湛。
6. 深入掌握微生物工作中所使用的实验室检测方法。
7. 精通微生物分析的方法与操作。
8. 具备出色的研究论文和技术报告撰写能力。
9. 具备分析思维，拥有较强的概念性思维和研究技能。
10. 是注重精准度和细节的强有力领导者。

Qualifications:
1. Degree in microbiology, biochemistry, or related fields, with a preference for a doctoral degree.
2. 1 year of work experience as a microbiologist.
3. The ability to plan and execute experimental protocols.
4. Have in - depth knowledge of electron microscopes, electronic equipment, chemical samples, stains, and weighing equipment.
5. Be highly skilled in microbiological techniques, methods, equipment, and consumables.
6. Have a deep understanding of the laboratory testing methods used in microbiology work.
7. Be proficient in the methods and operations of microbiological analysis.
8. Have excellent writing skills for research papers and technical reports.
9. Have an analytical mindset and strong conceptual and research skills.
10. Be a strong leader who pays attention to accuracy and details.