Xin (Summer) Yang Email & Phone Number

Mississauga, Ontario, Canada

· Method Development & Method Validation for In House methods· Write and review Standard Operating Procedures (SOP)· Performed routine tests for raw material and finished product, using chemistry analytical and instrumental techniques; such as weighing, sample and standard solution preparation, titration, FT-IR, pH meter, HPLC· Assisted in the OOS investigations and suggested corrective and preventative action· Generate Certificate of Analyst for the finished product according to the lab test result.· Lab reagent control.

Mississauga, Ontario, Canada

· Prepare and execute temperature mapping protocol for sample retention room with following studies: Empty and Loaded room temperature distribution study, Power-loss Recovery Study, Door-open Recovery Study, etc.· Experience on sterile environmental monitoring with well-trained gowning skill: particle count test, air microbial test and surface contact test.· Support cleaning validation: Sanitation of mixing tank and filling line.· Set up sample control system by creating a set of SOP and forms.· Familiar with ERP system for product releasing.· Review and maintain documents including laboratory testing record, work order, certificate of analysis, etc.· Conduct inspection for manufacture process.· Conduct internal audit for preparation for Health Canada auditing.· Document control.

Linfen, Shanxi, China

• Improved the process of a new product, develop a solvent-free and no waste acid synthetic method of α- acetyl -γ- butyrolactone. After 86 experiments, the yield increase from 78% to 91%.• Simplified the purification process of the product, cut down 2 operation units (heating and liquid separation), which can save up to 40k dollars for this process.• Designed the process flow diagram and piping and instrumentation diagram with AutoCAD, helped to install some common pilot scale equipment, like rectifying column.• Skilled in using some measuring instrument, like Gas Chromatograph, Liquid Chromatograph, FTIR, DTA• Documented the experiments data and reported every week.

Master'S Degree, Chemical Engineering, 86

Core course: Applied Engineering Mathematics, Special Topics in Biochemical Engineering (Tissue Engineering), Interfacial Phenomena.

Bachelor'S Degree, Chemical Engineering, 83

Core course: Experimental Technology, Graphing of Engineering, Organic Chemistry, Unit Operating Principle and Design, Physical Chemistry.