Yan Chen, Phd Email & Phone Number

Shanghai, China

Shanghai, China

Biologics in China NDA QC testing; Registration specifications; Direct contact with HA;Post approval management; CMC variation preparation and submission.

Shanghai, China

Authoring Module 3 for CTA and NDA;Authoring China specifc regulaotry documents; MTP, China Annual Reprot etc;Responsible for CMC Change Control regulatory impact assessment;Responsible for CMC related RTQ during CTA or BLA;Support BLA QC testing at NIFDC;Managed Submission lifecycle management/CC using Veeva Vault system;

Shanghai Suburb, China

CMC Project Management for IND-enabling projects (NMPA, FDA, dual-filling). Managing timeline, scope, budget and client relationships. Coordinate internal resources and timeline. Responsible for contract drafting, hosting meetings, hosting client visit, cross-functional technical discussion. Manage domestic and international IND/post-IND submission.

Shanghai Suburb, China

CMC Project Management for IND-enabling projects (NMPA, FDA, dual-filling)

Shanghai Suburb, China

Working as upstream technical lead in IND-enabling project. Hands-on experience in upstrea, process development design and execution. Seed train design, cell culture process development, bioreactor production, scale-up, non-GMP pilot plant production, et al.

Shanghai Suburb, China

• Work as downstream purification scientist in IND-enabling projects. Hands-on experiences with antibody purification process development. My work includes all steps in downstream process development.Experienced with.
• Early stage fast pool pilot plant production
• Early stage process development
• non-GMP pilot plant production
• GMP production
• Viral clearance studyWorked as project lead for internal technical project. Research study about antibody reduction prevention. Developed antibody reduction scale-down model still in use.

Singapore

After graduation, I continue to work for my Ph.D. supervisor (same lab, similar work).

Singapore

I work in Center for BioImaging Sciences (a research center at National University of Singapore) among several other bioimaging interdisciplinary research teams. I am an expert in single molecule tracking and have experience doing image processing (coding using MATLAB and ImageJ). I summarize my work experience and skills as follows: Five-year experience.

Beijing City, China

• College fourth year, I joined a industrial bacterial fermentation lab at Institute of Microbiology, Chinese Academy of Science in Beijing. My work and responsibilities were as follows:
• Molecular clone: primer design, PCR, plasmids construction, restriction enzyme, ligation, mini-prep, transformation, competent cells generation, bacteria culture & fermentation, reporter gene expression level testing.
• Biochemistry: SDS-PAGE, FPLC,
• bacterial fermentation, in petri dish, testing tube, shake flask, bioreactor, etc.

Tianjin City, China

College third year, I joined a microbiology fermentation lab.My work includes molecular cloning, media prep, bacterial culture, etc.

Tianjin City, China

• As a sophomore, I initiated a research project in a biochemistry lab. I tested the performance of several therapeutic resins. My major experience involves the following:
• Experiment design, small animals (rats, mice, once rabbits) handling, simple animals surgery, buffers preparing, resin packing, experiment report writing etc.
• Co-operating with local hospital and resin company, presenting at meetings.
• Writing & presenting grant application proposal, preparing mid-term inspection, and grant summary report.

Doctorate Degree, Cell Biology And Molecular Biology

Activities and Societies: American Society for Cell Biology (ASCB) Graduate student member (2014-2016); ASCB Annual conference 2014.

Bachelor’S Degree, Biological Sciences, General