Yan Fu

RA/ RA CMC @ Organon

About

• 10 years' work experience in CMC development. Good at CMC development, especially analytical method development, validation and transfer. • 5 years' work experience in regulatory affairs. Be familiar with IND, NDA and PAS. Be familiar with the GMP regulations and GMP inspection.

Country

China

City

Shanghai

Industry

Pharmaceuticals

Skill

CMC, GMP, Sop, Analytical Chemistry, Dissolution, Analytical Method Validation, Pharmaceutical analysis, Process development, analytical method development, 药品生产质量管理规范, 液相色谱法-质谱联用, 标准作业程序, 气相色谱法, 高效液相色谱法, 制药业, 分析化学, 气相色谱-质谱联用仪, FDA, Pharmaceutical Industry, High-Performance Liquid Chromatography (HPLC)

Experience

RA/ RA CMC

Organon

2021-5 - Present · 5 yrs 5 mos

中国上海市徐汇区

Reviewer and Inspector（审评员/检查员）

Shanghai center for drug evaluation and inspection上海药品审评核查中心

2017-12 - 2021-4 · 3 yrs 5 mos

负责药品的审评和检查。

Scientist II of Analytical Laboratory

Boehringer Ingelheim

2010-4 - 2017-11 · 7 yrs 8 mos

上海

• Provide highly efficient analytical support for synthetic process development (sythetic process optimization and reference material synthesis) including analytical method development, reaction monitoring, and analytical troubleshooting. • Collaborate with synthetic process development labs to generate technical packages for API starting materials and intermediates. Support technical transfer of chemical process to suppliers regarding scale-up and trouble-shooting. • Responsible for analytical method development, validation and transfer. Perform impurity preparation and identification. • Perform all kinds of analytical technologies (HPLC, GC, LC/MS, GC/MS, prep. LC, ICP-OES, DSC, TGA, IR, UV, and Titration) during daily work. • Perform release testing of API starting materials, intermediates, and API in compliance with cGMP regulations.

Scientist of Pharmaceutical Analysis/Group Leader

Frontage Laboratories, Inc

2007-7 - 2010-4 · 2 yrs 10 mos

上海

• Responsible for developing, performing, validating and transferring analytical methods for quantitative and qualitative chemical analysis of Active Pharmaceutical Ingredients (API), Drug Products, and Related Materials. • Qualify reference standard. Optimize existing methods and provide analytical support for development activities. • Prepare protocols and reports for method validation, transfer and stability testing. • Review notebooks and data packages in terms of accuracy and consistency in compliance with FDA, ICH guidelines and company SOPs. • Be familiar with cGMP/GLP management procedure. Be capable of writing SOPs.