Lucas Ji

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

Country

China

City

Suzhou

Industry

Biotechnology

Skill

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

Virtue Diagnostics

Senior Scientist(Team leader)

Virtue Diagnostics

LinkedIn
2023-4 - 2026-1 · 2 yrs 10 mos

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.

Virtue Diagnostics

CEO Assisant(Part-time)

Virtue Diagnostics

LinkedIn
2024-1 - 2024-6 · 6 mos

中国 江苏省 苏州市

Virtue Diagnostics

Scientist

Virtue Diagnostics

LinkedIn
2021-9 - 2023-3 · 1 yr 7 mos

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).

蓝怡科技集团人才中心

Sr R&D Engineer

蓝怡科技集团人才中心

2020-5 - 2021-9 · 1 yr 5 mos

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.

上海奥普生物医药有限公司

R&D scientist

上海奥普生物医药有限公司

LinkedIn
2016-6 - 2020-5 · 4 yrs

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.

Education

East China University of Science and Technology

East China University of Science and Technology

LinkedIn

Biomedical/Medical Engineering

2020 - 2023 · 3 yrs

Lucas Ji's Contact Information

Email

******@***.com

Phone

(**) *** ****

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