Lucas Ji
Senior Scientist(Team leader) @ Virtue Diagnostics
About
With highly seasoned professional and extensive expertise in understanding diagnostics, R&D and production process of chemiluminescenc、fluorescence chromatography platforms, able to independently complete the R&D and registration ,familiar with EP on performance establishment and evaluation. Familiar with SPSS, Excel based The SAS plug-in and minitab statistics Software, and Basic understanding of VBA and statistics
China
Suzhou
Biotechnology
Assay Development, Immunology, Global R&D, Clinical Laboratory Testing, IVDR, IVDD, ISO 13485, IVD , troubleshotting, Research and Development (R&D), Formulation, Biotechnology, Management, Medical Devices, Life Sciences, Research, Manufacturing, Pharmaceutical Industry
Experience

Senior Scientist(Team leader)
苏州市
1.Responsible for the development, transfer and validation of new products TG, Anti-TG, Calciton (chemiluminescent) on SuperEffic and provide performance data for registration, and assist in the NMPA registration. 2.Responsible for the development, transfer, validation, clinical and registration of HBCAb and HBeAg(chemiluminescent) for infectious diseases on Superflex. 3.Lead and mentor peers to have high problem-solving and executive capability during project implementation. 4. Worked in Brazil (Labtest) for three months to support the Brazilian factory technology transfermation and performance validation of domestic chemiluminescent products. 5.Performance validation work, sample survey, familiarize with EP documents and domestic industry standard. 6.Support domestic product transfer to Brazil and Indonesia sites.

Scientist
中国 江苏省 苏州
1.Responsible for the project development, design transfer, design verification, design validation of chemiluminescence TG,Anti-TG; CT, understanding DI, DG, DT, DO phase work and ISO13485 system work, and obtained IVDD certificate, and domestic registration work. 2.Responsible for the development,and registration of general reagents: pre-trigger, trigger,washing buffer, system maintenance fluid; and obtained four IVDR certificates, and also owns the patents of this product. 3.Responsible for technology transfer and validation of Indonesian and Brazilian products, providing performance evaluation data for Indonesia and Brazil, and assisting in registration work (import registration and local registration).

Sr R&D Engineer
蓝怡科技集团人才中心
中国 上海市 闵行区
1.Responsible for the research and development of chemiluminescent thyroid markers, raw material selection, process reaction system construction, traceability system construction, performance establishment and evaluation, transfer and registration related work. 2.Responsible for 5S management in the laboratory.

R&D scientist
中国 上海市 浦东新区
1.Investigated the market for dry fluorescent CRP kits formulated quality standards, process protocols, etc., 2.Research on chemiluminescent IL-6, output market research report, and performance indicators of kits from competitor, which were not developed due to the company's strategy. 3.Participate in R&D to optimize the chemiluminescent Troponin I kit. 4. Other R&D support type of work, developing SOPs, etc.
Lucas Ji's Contact Information
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