Xinwen Shi

About Xinwen Shi

I\'m currently a scientist of downstream MFG at WuXi Biologics, familiar with downstream processing including column chromatography (AC, AEX, CEX), viral filtration, viral inactivation and neutralization, depth filtration, UF/DF, and bulk fill. I am also responsible for manufacturing CQV activities including URS, SIA/CAI, risk assessment, ERES, DQ, etc. I graduated from Columbia University with MS in Chemical Engineering with a concentration in Biotechnology and Biopharmaceutical. Four years of laboratory experience enabled me to master operating analytical equipment for both chemical and biochemical experiments. In addition, I have gained insights into various pharmaceutical research. These experiences and studies coping with diverse fine chemicals urged me to pursue my passion in the pharmaceutical industry. I am an enthusiast in devising efficient, sustainable, tech-orientated methods for the production of clinical therapeutics, cosmetics, and food. I am confident in my articulate and professional speaking abilities and have developed excellent presentation and negotiation skills. I will be a great asset in any research setting, so if you are looking for someone with my skillset and passion, please feel free to reach out!

Experience

1. Senior Associate Scientist

   WuXi Biologics

   Jul 2022 — Present · Cranbury, NJ, US

   Developed 6 projects in GMP run in a year with the purification team, from column chromatography (AC, AEX, CEX), viral filtration, viral inactivation and neutralization, depth filtration, UF/DF, to final bulk fill in a startup CDMO environment; Assisted in the implementation of AKTAprocess Skids and Cogent Process-Scale TFF System• Worked on manufacturing CQV (Commissioning, Qualification, Validation) activities, including URS, SIA, risk assessment, ERES, etc.• Revised MBRs to align with process updates and provided ease of execution• Drafted, revised and reviewed SOPs and OJTs, executed manufacturing documentation and resolved issues in accordance with Change Controls, CAPAs, and identified improvements• In charge of the department’s equipment and consumables procurement; Responsible for manufacturing assets management; Audited with the finance team for over 400 pieces of equipment and instrument

Education

• ShanghaiTech University

  Bachelor's degree, Chemistry

• Columbia University

  Master's degree, Chemical Engineering