Yang Li

** ******* ******, ******* **, Canada, M*V 3K8

Highlights of Qualifications

Master's degree in Chemical Engineering and Bachelor’s degree in Biotechnology

More than 6 years of working experience in performing, developing, optimizing, synthesizing, monitoring, analyzing, testing, managing and controlling quality of chemicals, intermediates and final drug products in the R&D Department of Bayer Limited and Roche Pharmaceuticals Ltd.

Assistant Engineer certificate and deep knowledge of analytical assessments and quality protocols

Strong understanding of Quality Management System including quality analysis, quality manual, quality policy, quality objective, quality assurance, quality control, document control, cGMP, GLP, LIMS, FDA and ICH guidelines and experience in reviewing Standard Operating Procedures (SOPs)

Excellent knowledge of application of Quality standards (ISO 9001, ISO 13485, ISO 18000, ISO 17025, ISO 14001, ISO 50001), USP/NF, FDA, EPA & CALA rules and regulations

Well acquainted with Chemical Engineering, Bioengineering, Computer Science, Analytical Chemistry, Biological Chemistry, Organic Chemistry, Medicinal Chemistry, Electrochemistry

Proficient in performing multi-step organic synthesis, synthesis of complex organic molecules, novel biomedical research chemicals and their analogues (or derivatives) and metabolites

Highly skilled in techniques including NMR, FTIR, GC-MS, HPLC, DSC, ICP-AES/MS, ultraviolet-visible (UV-Vis) spectroscopy, fluorescence spectroscopy, pH meter, gel permeation chromatography (GPC), thermogravimetric analysis (TGA) and cyclic voltammetry (CV)

Good at programming: C/C++, SQL, Java, AutoCAD, MATLAB, MS Office, MS Project, LIMS, ChemStation, ChemDraw, Chemspider, Chemical Abstract Services (CAS), Scifinder, Scopus

Solid theoretical background in Pharmaceutical Engineering and Chemical Engineering such as organic synthesis, separation and purification, extraction, and chemical analyzing and testing

Expertise in the process of analysis, assay, chemical detection, rectification, Karl Fischer, distillation, supercritical fluid extraction, absorption, evaporation, heat exchange, and mass and heat transfer

Strong theoretical foundation of wireless networking and network protocols: HTTP, FTP, IP, TCP

Adept at the use of computer in the operating system: DOS, Windows, iOS, Unix/Linux, Mac OS

Reliable, high sense of responsibility, excellent written and verbal communication skills

Quick learner, strong team player, and brilliant problem analyzing and solving abilities

Education

Pharmaceutical Quality Control Program Sept. 2016 - Dec. 2016

Quality Assurance Specialist Program Jan. 2016 - Aug. 2016

Master of Chemical Engineering Jan. 2013 - Mar. 2015

University of Ottawa, ON, GPA: 3.7/4.0

Certificate of Assistant Engineer 2012

Bachelor of Engineering, GPA:3.6/4.0 Sept. 2005 - July 2009

Bachelor of Biotechnology, GPA: 3.9/4.0 Jan. 2006 - July 2009

East China University of Science and Technology (ECUST)

Papers & Publications

Synthesis of poly(aminopropyl/methyl)silsesquioxane particles as effective Cu(II) and Pb(II) adsorbents Journal of Hazardous Materials, 2011, 196:234-241.

Career Achievements

Chemical Technician, Germiphene Corporation Sept. 2016 - Feb. 2017

Performed testing and analysis of raw materials and finished products using SEM, PCR, ELISA, HPLC, GC, TLC, NMR, FTIR, ICP-MS, UV-Vis, IEC, Atomic Absorption Spectroscopy

Applied wet chemistry techniques such as specific gravity, hardness, friability, disintegration, dissolution, water content using Karl Fisher, viscosity and standardization by titration

Calibrated pipettes, balances and other laboratory instruments according to established written work instructions and maintained precision and hygiene of equipment

Executed method development and method validation of HPLC and GC using Empower software, and developed and validated test procedures and set-up specifications for dissolution

Carried out both non-standard and special tests and analyses, associated with station chemistry, hazardous material identification, water treatment, and environmental monitoring processes

Drafted technical reports based on experimental data, calculations and observations, identified OOS/ OOT test results, performed root cause analysis and implemented corrective and preventive actions

Managed product sample retention, quality testing, and inspection of product shelf life and expiry date thereby isolating products that did not meet standards

Created and improved documentation of equipment maintenance, calibration data, supply inventory, Safety Data Sheets (SDS) and Certificates of Analysis (COA) into laboratory software (LIMS)

Ensured that all work was performed in compliance with SOPs, GMP, HACCP, SQF, WHMIS standards, CFIA regulations and established Safe Work Practices (SWP)

R&D Specialist, University of Ottawa Sept. 2014 - Aug. 2015

Investigated and analyzed the mass transfer and heat transfer under vacuum membrane distillation (VMD) process for a single component feed and the effect of backing materials on the performance

Explored studies about VMD with continuous system and developed a new model of the dead-end feed set-up for single component (water) transport process and demonstrated that the supported materials reveal the effect on the performance of PVDF membranes

Developed a super solid desiccant based on superabsorbent polymer and proved to achieve 276% of water vapor absorption capacity which showed big potential in application in pharmaceutical industry

Interfaced with chemical engineers and process scientists to improve process control and facilitate analysis of task breakdowns, as well as developed and validated new analytical procedures and methods to raise efficiency and eliminate mistakes using LIMS, MS Office and MS Project

Analyzed and verified samples using microscopy, TLC, GC, HPLC, NMR, FTIR, UVS, as well as optimized and validated analytical methods to assess the quality, purity and stability of chemicals

Executed guidance to the performance of analytical operations and prepared process development project proposals and reports, experimental protocols, process flow diagrams and technical reports

Conducted routine laboratory and non-conformance investigations under GMP guidelines, and completed all training assignments and GLP practices as well as SOP and GMP documentation

Executed Lab investigations to identify the root cause of any Out-of-Trend or Out-of-Specification, resolved quality and system issues, and completed Corrective Action Reports (CARs)

R&D Technologist, Bayer Limited July 2009 - Dec. 2012

Provided supervision and technical support for manufacturing processes in Laboratory Manufacturing and Production Plant from lab scale products to full scale production of medicines

Supervised and maintained facilities and instruments in a clean and hygienic manufacturing area and controlled environmental conditions in order to prevent cross contamination of food or drug products

Designed protecting group strategies, multi-step synthesis and purification of complex organic molecules for medical research and analyzed intermediates and products using GC, HPLC, NMR

Performed research and analysis to develop and optimize different active pharmaceutical products and intermediates, and modified polymeric drug delivery carriers to change the release time

Executed the library synthesis of 2-substituted pyrimidines and 4-aryl-2-anilinopyrimidine compounds, which were major building blocks for several pharmaceutical compounds

Synthesized Acadesine (AICA-riboside) to get two-fold increase in yield compared to literature method and successfully scaled up the process for large scale synthesis

Collaborated with process chemists and technicians to ensure maximum output levels, monitored and analyzed the production, and reduced the number of steps in the synthesis of Nifedipine

Conducted experimental studies to recommend process improvements, shortened the production cycle and increased the productivity of Cetirizine Hydrochloride with a 30% cost saving

Optimized and scaled up the Pd catalyzed Münchnone synthesis and applied the method in Lipitor (Atorvastatin) synthesis which was the world's bestselling drug used primarily as a lipid-lowering agent and for prevention of events associated with cardiovascular disease

Reviewed and optimized processes and process controls for existing products to reduce costs and evaluate risk of new product scale up while maintaining product quality

Led root cause investigations of production limitation and assisted in execution of corrective and preventative actions for process-related non-conformances to manage process control tasks

Completed Standard Operating Procedures (SOPs) for analysis processes and prepared Validation Plans and Protocols, and Common Technical Document (CTD) for registration of new formulations

Evaluated and ensured the ingredients and products met CFIA and internal standards, accomplished all ISO 9001 related quality control documents and completed training of GMP in Bayer Limited

Coordinated with logistics, quality control, analytical R&D, materials management and inventory to ensure efficient shipment of high quality products and solution to customers

General Researcher, Shanghai Roche Pharmaceuticals Ltd. Mar. 2007 - May 2008

Reviewed comprehensive literature, scientific journals, related to drugs under investigation in the area of structure, stereochemistry, synthesis and spectral characterization

Staffed with industrial scientists and chemist, and tasked with applied research in scientific fields in order to facilitate new product development and innovation

Managed the quality of Production of Capecitabine and controlled the process for laboratory research to ensure the uniformity, quality, and integrity of chemicals and products met customer requirements

Improved a novel synthetic approach to 1,3-oxathiolanes which was patented and implemented in a process for the production of an active pharmaceutical ingredient

Developed robust, safe and effective implementation and scale-up of a seven-step API production process, which was successfully transferred to an international production site

Carried out research and development, quality assurance, quality control, cooperated with academic research groups and built connections between fundamental research and industrial applications

Conducted physical and chemical tests for starting materials, intermediates and finished products for compliance to specifications according to GMP and safety requirements within established deadlines

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