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Wei (Vickie) Cui

**** ********* ****

Clarksville, Md 21029

Tel: 443-***-**** (cell)

Email: addr7k@r.postjobfree.com

CAREER OBJECTIVE:

A motivated and dedicated professional with more than twenty-five years of experience in research development, method transfer, and quality control seeks a Research Scientist/QC Scientist position where I can develop and excel while giving my best to the employer. SUMMARY OF QUALIFICATIONS:

• 15 years’ experience in the pharmaceutical and BioTech industry as a senior chemist, working on quality control, conducting HPLC, GC, cIEF, BioA, QPCR, ELISA, dissolution, particle size with Horiba, Karl Fischer, appearance, TOC, Raw Material testing per USP methods, and data review, etc.

• Multiple years’ experience with method transfer and validation – review CMC documents, write SOPs, validation protocols, validation reports and test methods, execute the protocols, test real samples at validation, registration and development stages and facilitate document training.

• 2 and years’ experience as a research chemist with FDA/CVM conducting method development and validation.

• Strong laboratory skills, working experience with state-of-the-art laboratory instruments such as LC/MS/MS, GC/MS, GPC, HPLC, UV-VIS, GC, CE, iCE3, BioA, QPCR, IR, AA, ICP, X-Ray Fluorescence, Dissolution, Horiba, Karl Fischer and TOC. Extensive experience with Chemstore/Chemstation, Empower, LIMS and Trackwise for root cause investigation and SAP enterprise software.

• 2+years’ experience with database design, development, and maintenance via Microsoft Access.

• 2 years’ as a lecture in a university in China.

• About 40 credit hour graduate level courses in inorganic chemistry/organic chemistry/advanced analytical chemistry.

• Well-organized, goal-oriented, diligent, attention to details. HONORS AND AWARDS:

• Graduate Student Academic Excellence Award, Department of Chemistry, George Mason University (5/2000).

• Asian Heritage Distinction Award, Office of Minority Student Affairs, George Mason University

(4/2000).

• Graduate Research Fellowship, Graduate Dean’s Office, George Mason University (Fall/1999).

• Outstanding Graduate Research Award, Liaoning Normal University, Dalian, China (8/1989). PROFESSIONAL EXPERIENCE:

AstraZeneca PLP, Frederick, MD, QC Department, 11/2011 –08/2018 Senior QC Analyst

• Conducted Reversed Phase-HPLC, HPSEC, HIC, IEX, UV-Vis A280, ELISA, CE, cIEF, BioA, QPCR, and GC testing on in-process drug substance and finished drug products.

• Led and performed method transfer and validation tasks for some projects. Wrote, reviewed, and approved SOPs, validation protocols and validation reports.

• Led change for the revision of existing assays in accordance with internal processes and consistent with GMP, GLP and GDP requirements, as possible. 2

• Coordinated complex projects with other departments such as Quality Assurance Department, MS&T and statistical group and interacted with other department personnel to accomplish objectives.

• Delivered high quality services on all work to both internal and external customers.

• Strictly followed GMP, GLP, GDP and regulations throughout my work. Conducted analytical testing in an organized manner and provided high quality and accurate results in time.

• Conducted execution, documentation, and review of testing as required to support product release, stability, and validation studies.

• Worked as a SME for iCE3 and GC instruments. Have multiple years of experience with instrument troubleshooting techniques for HPLC, iCE3 and GC.

• Participated in iCE3 and GC instrument IOQ tasks.

• Served as QC interface with MS&T on validation projects and with vendors for instrument service.

• Coordinated with manager to ensure successful investigation of exceptional conditions or atypical data.

• Utilized trackwise system for non-conformance and OOS investigation activities. Wrote CAPA documents.

• Provided technical guidance and training for peers and lower level team members.

• Participated in lab ownership, monthly logbook review and lab safety inspection.

• Conducted reagent and instrument parts inventory.

• Conducted 6S implementation for cIEF and GC benches in lab Q100, which saved the labor, time, and resources. Obtained a yellow belt project certificate in 2017. Shire Pharmaceuticals, Inc., Owings Mills, MD, QA / QC Department, 10/2004- 11/2011 Chemist

• Conducted HPLC analysis, residual solvents testing using GC, dissolution, particle size using Horiba, Karl Fischer, appearance, TOC, % solid, Raw Material testing per USP methods, data review, notebook/raw data archive, etc.

• Performed deviation, Out- of- Specification and Out-of-Trend investigations using Trackwise.

• Very proficient with writing and revising SOPs.

• Gained a great amount of experience with identifying and troubleshooting analytical equipment problems and individual assays.

• Provided guidance and training for group members and peers.

• Conformed to all cGMP/GDP/GLP and regulations.

• Led method transfer for Vyvanse in the Pharm Analysis team for two years. Method transfer tasks included reviewing CMC document; drafting SOPs, protocols and test methods; executing protocols; testing real samples at validation, registration and development stages; facilitating document training and conducting sample inventory.

• Attended some outside professional training sessions such as GxP, Method Validation/Transfer Methodologies and Principles, new instrument application, and analytical instrument maintenance and troubleshooting, etc. Applied those knowledges in my tasks.

• Conducted monthly lab safety audit to ensure safe work environment. Active committee member - Plant Chemical Hygiene Committee.

Pharmaceutics International, Inc., Hunt Valley, MD, Dissolution Group, 2/2004-10/2004 Chemist

• Conducted dissolution and HPLC analysis on in-process and finished pharmaceutical products. Generated results in a timely manner with high accuracy and productivity. Ensured high clarity notebook records.

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Center for Veterinary Medicine, FDA, Laurel, MD 8/2000- 3/2003 Chemist

• Collaborated with a principle investigator in the validation of a method for determination of pentobarbital in dry dog foods by gas chromatography/mass spectrometry (GC/MS).

• Conducted local survey of pentobarbital concentration in dry dog foods containing animal fat or meat and bone meal using GC/MS.

• Conducted the study for screening and confirmation of multiple drug residues in eggs by liquid chromatography/ion trap tandem mass spectrometry (LC/MS/MS).

• In collaboration with colleagues, designed and developed a Microsoft Access based database for division chemical standards. The system allows users to conduct queries about chemical standards and other specific purposes.

• Developed multiple residue/multiple species methods to screen for drug residues in aquaculture products: shrimp using LC/MS/MS.

• Independently conducted analysis of Ceftiofur and Cephapirin in Bovine Milk using HPLC. Provided important information for division decision making regarding those two chemicals in milk products.

George Mason Univ., Dept. of Chemistry, Fairfax, VA 8/1998–8/2000 Graduate Research Assistant

• My research project focused on the incidence and spatial variation of PCBs, PAHs, and PCDFs in sediments from the Washington area Potomac River Watershed. Gained a great deal of experience for analyzing PCBs and PCDFs using GC/ECD and PAHs using GC/MS. Virginia Commonwealth Univ., Dept. of Chemistry, Richmond, VA 8/1997-8/1998 TA/Summer Graduate Research Assistant

• Recitation and chemistry lab instructor for Chemistry 101 (General Chemistry), Chemistry 102

(General Chemistry), and Chemistry 101 Lab (General Chemistry).

• Conducted research on characterization of Reversed-Phase Liquid Chromatographic Stationary Phases using solvatochromism and multivariate curve resolution. The use of solvatochromic dyes allows the identification of the different factors contributing to the overall polarity of the solvent medium.

Anshan Iron and Steel Institute, China. Dept. of Basic Sciences, 9/1989–5/1991 Lecturer

• Taught two undergraduate courses: (1) Analytical Chemistry, and (2) Technical English Reading.

• Supervised undergraduates in their thesis research. SPECIALIZED TRAINING:

6/2014 Deviation management and CAPA webex training. 5/2014 iCE 3 and MFI meeting: Protein Simple.

5/2014 GC/MS Users Meeting.

2/2014 OpenLab Intelligent Report; Agilent.

4/2010 Interpretation of Mass Spectra: LC resources. 10/2009 Advanced Dissolution: U.S. Pharmacopeia.

7/2009 Trouble Shooting LC System: ACCTA. Inc.

9/2007 Advanced HPLC Method Development: LC Resources. 10/2006 6890 GC Maintenance and Training: Agilent Technologies. 8/2006 Methods Development, Validation Procedures, and Regulatory Compliance Issues for the Pharmaceutical and Related Industries: American chemical Society. 3/2001 Introduction to Mass Spectrometer: One-day training at Pittcon 2001. 3/2001 LC/MS, GC/MS, and MS/MS with Quadruple Ion Trap Mass Spectrometers: One-day training at Pittcon 2001.

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COMPUTER SKILLS:

• 25-year experience with MS Windows 2000/NT.

• 25-year experience with Microsoft Office (Word, Excel and PowerPoint).

• 2+year experience with database design, development, and management via Microsoft Access.

• Oracle DBMS.

• 6 credit hours of graduate course work in Advanced Database Management (relational database modeling, PL/SQL language, database design and programming, transaction processing, recovery, concurrency, security, integrity, etc.). EDUCATION:

• Graduate work in Analytical Environmental Chemistry George Mason University., Fairfax, VA

• Graduate work in Analytical Chemistry

Virginia Commonwealth University., Richmond, VA

• MS, Analytical Chemistry

Liaoning Normal Univ., Dalian, China

• BS, Chemistry

Liaoning Normal Univ., Dalian, China

PUBLICATIONS:

• Foster, G. D., Cui, V., PAHs and PCBs Deposited in Surficial Sediments along a Rural to Urban Transect in a Mid-Atlantic Coastal River Basin (USA). J. Environ Science and Health. Chem. 43:1333 (2008).

• Heller, D.N., Cui, V., Strategy for Confirming Multiple Classes of Animal Drug Residues in Eggs: Generic Solid Phase Extractions and Gradient Liquid Chromatography with Data- Dependent Electrospray-MS/MS on an Ion Trap Mass Spectrometer, 49th ASMS Conference on Mass Spectrometry and Allied Topics, Chicago, IL, June, 2001.

• Heller, D.N., K. M. Lewis, V. Cui. Method for Determination of Pentobarbital in Dry Dog Food by Gas Chromatography/Mass Spectrometry. J. Agric. Food Chem. 49: 4597-4602 (2001).

• Nigam, S., A. de Juan, V. Cui and S. C. Rutan, Characterization of Reversed Phase Chromatographic Stationary Phases Using Solvatochromism and Multivariate Curve Resolution, Anal. Chem. 71:5225 (1999).

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