北京招聘

Main responsibilities
1. Timely follow up product development and improvement. Cooperate with R&D in related validation.
及时跟进新产品和改进产品研发进展，并配合研发部进行相关验证评估工作。
2. Lead NPI process development and confirmation.
实施新产品转化时的工艺研究和工艺确定。
3. Develop production processes and other documents for pilot products and new ones. Provide instruction of relevant files for Production department.
制定试产品、新产品的生产工艺规程等文件，指导生产部进行相关文件的制定。
4. Pilot and transform production with cooperation of other departments.
和各部门进行新产品的试生产工作。
5. Validation of new product process, process optimization and batch size adjustment.
和各部门进行新产品的工艺验证工作；在线产品工艺、批量等调整后的验证工作。
6. Track and evaluate the quality of online products. Provide suggestions and improvements.
对在线产品进行质量跟踪和评估，适时提出改进和建议，并实施质量改进。
7. Improve the manufacturing process and procedure in order to ensure the production run smoothly.
对产品的生产工艺和流程进行改进，确保生产工作顺利进行。
8. Develop and train operators and make sure they have skills to do their job properly.
开发和培训操作员并确保他们有正确工作的技能。
9. Deal with product problems or customer complaints in time by retrospection and investigating.
指导产品发生质量问题或客户投诉时及时追溯或调查。
10. Participate in the CFDA certification, evaluation related work with cooperation of other departments.
参与并配合各部门进行CFDA的认证、考核相关工作。
Education
Bachelor degree or above, major in Molecular Biochemistry, Biochemistry, Biology, Medicine or related science.
Required work experience related to position
1. Beyond 5 years work experience in NAT Diagnostics.
核酸检测行业5年以上工作经验。
2. Familiar with NAT-related technologies, instruments, software’s, etc.
熟悉核酸检测相关的技术原理、实验操作、数据分析、仪器设备及软件应用。
3. Be able to design basic PCR primers and probes.
熟悉PCR引物、探针设计。
4. Be familiar with validation, be able to organize validation independently and be familiar with validation documents writing.
熟悉验证过程，能独立的组织验证，并熟练编写验证相关文档。
5. Have experience to generate the reagent manufacturing processes; familiar with the related equipment, GMP and ISO 13485 system. 熟悉核酸产品的生产流程、生产设备，熟悉GMP法规和质量管理体系法规。 6. Be familiar with the datum analysis tools and quality assessment software, know about the related knowledge of risk analysis. 能熟练的运用数据分析工具和质量评估软件，并了解风险分析相关知识。
7. Good team spirit, communication skills and hard working.
良好的团队精神和沟通能力,并且能够吃苦耐劳。
8. Good English skills. Candidates who passed CET-6 are preferred.
良好的英文能力，通过英语六级者优先。

PerkinElmer Instruments (Shanghai) Co.,Ltd ( US company)

PerkinElmer is a global scientific leader providing an extensive range of technology solutions and services to address the most critical issues facing humanity. From critical research and prenatal screening to environmental testing and industrial monitoring, we’re actively engaged in improving health and enhancing quality of life all around the world.
PerkinElmer’s proud history dates back to the 1930s.Our legacy of scientific advancement, operational excellence and continual expansion, from Boston to Beijing, is the foundation of our mission to improve human and environmental health.
Collaborating with customers to identify risks, discover and monitor the things that matter most—from safer drinking water to cleaner air, faster research to healthier babies—is imperative to executing our mission.
Encouraging ingenuity and exploration; integrity and generosity; and, teamwork and employee development is essential to living our mission, every day.