Development Quality Control

Zhaoxia Liu

** *. ******* ***. *-mail: **********@*****.***

Chatham, NJ 07928 Phone: c. 973-***-****, h. 973-***-****

Summary

• Analytical chemist with 8 years of experience in chromatography and 5.5 years of pharmaceutical industry experience.

• Comprehensive knowledge in solid state science-related fields. Specialized in analytical method development and validation from raw material to API using analytical techniques.

• Quick learner and critical thinker with strong analytical, project coordination and interpersonal communication skills. Highly motivated to work in a science –focused and challenging environment. Strong problem solving and trouble shooting skills.

Professional Skills

• Spectroscopic Techniques

o Liquid Chromatography/Mass Spectrometry (LC/MS) on single-Q, triple-Q, TOF, and Q-TOF

o ICP-OES, ICP/MS, UV-Vis, IR, X-ray, Raman, and NMR

• Chromatography

o High Performance Liquid Chromatography (HPLC) and Ultra Performance Liquid Chromatography (UPLC) with RI, UV and PDA detector;

o Direct-Injection and Headspace Gas Chromatography (GC)

o Ion Chromatography (IC) and Size Exclusion Chromatography (SEC)

• Other Analytical Techniques

o Dissolution and Particle Size Analysis

o Karl Fisher Titration

o DSC, TGA and Optical Rotation Analysis

• Proficient in various regulatory guideline: ICH, USP, GMP and GLP

Work Experience

Novartis Pharmaceuticals Corporation, Method development & Validation (MDV) / Quality Control (QA), April 2012 – Present, Senior Scientist, Suffern, NY

• Planned, developed and validated robust analytical methods (Assay/Impurity, Dissolution, CU, Residual Solvents, KF, Titrations, etc) for drug products.

• Ensure timely and right first time method transfer to/from other sites, including the issue of protocols and reports.

• Strong support in the manufacturing plant in the investigation and cleaning validation.

• Authoring, reviewing and approving analytical documents including specifications, test methods, protocols and reports for method validation and method transfer for drug products.

• Authoring and reviewing SOPs.

Novartis Pharmaceuticals Corporation, Chemical and Analytical Development (CHAD), Senior Scientist, 2006 – Present, East Hanover, NJ

• Specialized in detecting genotoxic impurities on ppm/ppb level by LC, GC, LC/MS

• Specialized in impurity identification and structure elucidation on the compounds during the process development

• Coordination of LC/MS instrument maintenance. Familiar with softwares as Chemstation, MassLynx, and MicroTOF. Interaction with multiple vendors (Waters, Agilent, Bruker) regarding service, documentation requirements, instrument trouble shooting and annual preparative maintenance

• Administrator of open-access LC/MS lab. Strong technical support to all users, including instrument trouble shooting, maintenance, and helping with analyzing the spectrums.

• Administrator of ICP/MS & ICP/OES lab. Fully support with samples from process chemists and GMP releases for heavy metal analysis.

• Providing analytical support for drug substance manufacture in accordance with cGMP/GLP guidelines, using the following techniques: HPLC, GC, LC/MS, TGA, NMR, IR.

• Authoring analytical specifications, test methods, validation reports for drug substances, intermediates, and raw materials, and stability protocols and reports, and impurity profile reports for drug substances in TEDI and/or LIMS systems

• Providing analytical support for Pilot Plant Operations: raw materials, in-process control, intermediate and highly toxic/potent substances - method development, sampling, analyzing and cleaning validation

• Development and implementation of Global Generic HPLC methods

• Participated in development of an efficient HPLC chiral screening methodology – standard approach to chiral method development in CHAD

• Member of Analytical Initiatives Project Team

• Mentored summer interns

Novartis Pharmaceuticals Corporation, Chemical and Analytical Development (CHAD), Intern (05, 2006 – 11, 2006), Rotation (06, 2007, – 12, 2007), East Hanover, NJ

• Participated in salt programs and polymorph selections for early phase development projects

• Performing chemical stability studies on the drug substance properties

• Authored protocols and reports for salt screening and polymorphism

• Physical characterization on raw materials, intermediates, and drug substances in X-ray, Raman, DSC, TGA, and FTIR

• Studies on solvent-mediated polymorphic transformation and salts of optically active carboxylic acids

GlaxoSmithKline, Inc., May, 2005 - August, 2005, Parsippany, NJ, summer intern

• Automated Sample Preparation on Prelude Robotic Workstation

• Method development and validation of HPLC quantitative assays on APAP, Aspirin, Caffeine for products DAD and BACHARACH.

• Practice of the GMP documentation

Seton Hall University, Department of Chemistry and Biochemistry, September, 2003 – May, 2006

University of Mississippi, Department of Chemistry and Biochemistry, August, 2000 - May, 2003

• Designed and developed laboratory experiments in HPLC, GC and SEC

• Demonstrated and instructed instrument theory and application

• Taught Instrumental Methods of chemical analysis

Education

Seton Hall University, South Orange, NJ. 09/2003 – 05/2009, PhD

Doctor of Philosophy in Analytical Chemistry, May 2009

Thesis: The effect of adsorbent geometry and surface chemistry on HPLC retention

Seton Hall University, South Orange, NJ. 09/2003 – 05/2006, MS

Master of Science in Analytical Chemistry, May 2009

University of Mississippi, Oxford, 08/2000 – 05/2003, MS

Master of Science in Electrochemistry and Analytical Chemistry

Jilin University, Changchun, P.R.China, 09/1994 – 07/1998, BS

Bachelor of Science in High Polymer and Package Engineering

Honors & Activities

• Distinguished Graduate, Seton Hall University, 2009

• American Chemical Society (since May, 2002)

• Recipient of teaching assistantship in the department of Chemistry in Seton Hall University (September, 2003 – May 2006)

• Recipient of teaching assistantship in the department of Chemistry and in University of Mississippi, (August, 2000 – May, 2003)

• Excellent Graduate Student Scholarship-Jilin University, China ( July, 1998)

Workshop

• Short Courses: LC-MS LCT Premier Operation Training Course, Small Molecule Applications, Beverly, MA. June, 2009

• Short Course: Advanced HPLC Method Development. Princeton, NJ. August, 2005

Publications and External Presentations

• Z. Liu, M. Lin, R. Thompson, D. Drinkwater, S. Shah, Enantiomer Recognition of Primary Amine with 18C6H4 using HPLC and NMR Spectroscopy, paper in preparation

• E Loeser, Z Liu, M DelaCruz, V Madeppalli, Relationship between composition of

Acetonitrile-water mobile phase, Global Journal of Analytical Chemistry, Article in press, 2011.

• A. Giaquinto, Z Liu, A Bach and Y Kazakevich, Anal. Chem., 2008, 80 (16), pp 6358–6364

• E. Loeser, S. Babiak, Z. Liu, M. Girgis, P. Drumm, Journal of Chromatography A, Volume 1216, Issue 18, May 2009, Pages 3927-3932

• Z. Liu, R. Thompson, “Enantiomer Recognition of Primary Amine with 18C6H4 using HPLC and NMR Spectroscopy”, 2009 Csaba Hovath Symposium, Howard CT, April 2009

• E. Loeser, S. Babiak, Z. Liu, “Gravimetric Measurement of Excess Adsorption in a Binary Solvent System”, 2009 Csaba Hovath Symposium, Howard CT, April 2009

• Z. Liu, Y. kazakevich, “the effect of adsorbent geometry and surface chemistry on HPLC retention, 2009 Petershem Symposium, South Orange, NJ, April 2009

• Z. Liu, R. Thompson, M. Lin, D. Drinkwater, P. Drumm, “ Insights Into Enantiorecognition on a Crown-Ether-Based Chiral Stationary Phase by Reversed-Phase Liquid Chromatography and Nuclear Magnetic Resonance Spectroscopy”, 2008 Eastern Analytical Symposium, Somerset NJ, November 2008.

• Y. Kazakevich, Z. Liu, A. Giaquinto, “Synergistic effects of adsorbent’s geometry and surface chemistry on HPLC retention”, 2008 HPLC Conference, Baltimore, MD, May 2008

• Z. Liu, A. Giaquinto, A. Bach, Y. Kazakevich, “Characterization of commercially available HPLC adsorbents”, 2008 HPLC Conference, Baltimore, MD, May 2008

• Z. Liu, Y. Kazakelvich, ”Characterization of commercially HPLC columns” 2008 Petershem Symposium, April 2008

• Z. Liu, Y. Kazakelvich, “Chromatographic Behavior Of Reversed Phase Adsorbent In Reversed Liquid Chromatography”, 2007 Petershem Symposium, April 2007

• L. Feng, Z. Liu, P. Karpinski, “Investigation on Polymorphic Transformations of Api using Raman Spectroscopy”, The 2006 Annual Meeting, San Francisco, CA, November 2006.

• Z. Liu and C. L. Hussey, “Galvanostatic Pulse-plating of Cobalt-Aluminum Alloy in a Room-Temperature Chloroaluminate Molten Salt: Sigma Xi and Office of Research Student Poster Symposium, University, MS, April 4, 2002

REFERENCE

Available upon request

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