Yongquan Hou
Senior Director, Regulatory Affairs CMC @ WuXi Chemistry
About
Scientist with broad expertise in development and manufacture of small molecule and oligonucleotide drug candidates. Experienced in: • Chemical process development, using scale-down models and the DoE (with JMP) approach • Technology transfer and managing CMOs for GMP productions • Chromatography techniques (RP, SCX and SAX), including both analytical and preparative scales, and tangential flow filtration (TFF) • Analytical techniques for characterization of different types of molecules, including HPLC, UPLC, GC, IR, NMR, TLC, IC, XRD, and EA • ICH guidelines and CTD module 3 sections for IND, IMPD and NDA submissions
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United States
Biotechnology
Pharmaceutical process development, Manufacturing Scale-up, Technology Transfer, Medicinal Chemistry, Organic Synthesis, Chemistry, Polymer Characterization, Technical Leadership, HPLC, TLC, NMR, Drug Discovery, UV/Vis, Organic Chemistry, ChemDraw, LC-MS, Biotechnology, FTIR, High-Performance Liquid Chromatography (HPLC)
Experience

Process Development Scientist I
Cerulean Pharma Inc.
Waltham, MA
Led in-house development efforts to solve polymer issues and further understand the key polymer conjugation process. Established the process chemistry lab and increased in-house process capabilities In-house expert for Tangential Flow Filtration. Compiled and analyzed historical batch records (up to 10 years); presented the team with detailed findings and process improvement suggestions. Completed process description for historical batch records. Key contact person for external vendors for technology used in house or at CMO.

Reserach Investigator
Cambridge, MA
Evaluated syntheses from the Discovery group to target compounds; proposed and designed new and process-amenable synthetic routes for delivery of initial bulk quantities of material for toxicology studies (up to 1 kg of API). Proposed multiple research projects; led college interns for novel chemical methodology development and prepared draft for publication. Tech transfer from the in-house kilo-lab to the contract manufacturing organizations for GMP productions Process development work and stress tests to ensure successful GMP productions. Led contractors at CRO/CMO’s for process development work. Designed small molecule crystallization procedures to ensure desired and consistent polymorph and particle size distribution. Serve as head of internal kilo-lab group: maintained kilo-lab equipment; introduced new scale-up / scale-down equipment to the group; developed best kilo-lab practice to ensure safety and efficiency; trained group members for equipment use and best kilo-lab practice. Responsible for evaluation and selection of process modeling software (Dynochem) for the group; utilized Dynochem to model kinetic profile for chemical transformations (using ReactIR and HPLC) and simulated unit operations on both kilo-lab and plant scale. Responsible for evaluate synthesis-design software (ICSYNTH) for the group: proposed the idea to the management team and conducted initial interview and use-test. Prepared monthly reports and technical reports to summarize development work and propose future plans.

staff chemist
Worked on design and execution of multiple-step syntheses of unique chemical entities based upon SAR (structure activity relationship) studies in a highly collaborative team. Contributed to kinase inhibitor programs (oncology and neurodegenerative disorders) and imaging agent program.
Education

chemistry
Publication: Tan, Xiang-Hui; Hou, Yong-Quan; Huang, Chao; Liu, Lei; Guo, Qing-Xiang. “SnCl2-Mediated Carbonyl Allylation in Fully Aqueous Media” Tetrahedron 2004; 60; 6129-6136. Tan, Xiang-Hui; Hou, Yong-Quan; Shen, Bo; Liu, Lei; Guo, Qing-Xiang. “SnCl2/PdCl2-Mediated Aldehyde Allylation in Fully Aqueous Media” Tetrahedron Letters 2004; 45; 5525-5528. Tan, Xiang-Hui; Hou, Yong-Quan; Liu, Lei; Guo, Qing-Xiang. “SnCl2/Cu-Mediated Carbonyl Allylation Reaction in Water. Scope, Selectivity and mechanism” Chinese Journal of Chemistry 2004; 22; 450-454. Tan, Xiang-Hui; Zhao, Hui; Hou, Yong-Quan; Liu, Lei; Guo, Qing-Xiang. “Aqueous Barbier-type Reactions Mediated by Various Metals” Youji Huaxue 2004; 24; 987-1003. Tan, Xiang-Hui; Tao, Chuan-Zhou; Hou, Yong-Quan; Luo, Lin; Liu, Lei; Guo, Qing-Xiang. “Use of Cyclic Allylic Bromides in the SnCl2/Cu-Mediated Aqueous Carbonyl Allylation Reaction” Chinese Journal of Chemistry 2005; 23; 237-241.
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