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Development Training

Location:
Cleveland, OH, 44067
Posted:
March 12, 2012

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Resume:

Jin Zhang

**** ******* **., ***. ***

Northfield, OH 44067

Tel: 440-***-****

Email: kvtgjv@r.postjobfree.com

March 12, 2012

Dear Sir/Madam,

I am writing in response to the position of Chemist. I believe that my experience, skills and educational background make me an excellent candidate for this position.

As you will note on my resume, I have more than five-years of laboratory experience as a chemist in pharmaceutical manufacturing. I have hands-on experience in testing for raw materials, in process samples, finished products, and stability study by HPLC, GC, TLC, IR, UV, Auto-Dissolution, KF apparatus, and wet chemistry. I have sound working knowledge of method development, validation, and transfer. I am also knowledgeable of technical writing for new method, method validation protocol and report. In addition, I am familiar with USP/BP/EP, SOPs, cGMPs/GLPs, and FDA/ICH guidelines.

I have a Master Degree in Chemistry from York University, and I am trained for cGMPs/GLPs, method development/validation, as well as other required update according to the laboratory. These programs have provided me with the knowledge and skills required by the pharmaceutical industry. Additionally, I am a highly organized and result-oriented person. I am also an excellent team worker and enjoy working with a variety of people to strive for high quality work.

I would like to meet with you to further discuss my qualifications and how effectively I can contribute to your team.

Thank you for your time and consideration.

Sincerely,

Jin Zhang

Jin Zhang

9224 Lincoln Dr., Apt. G11, Northfield, OH 44067

Tel: 440-***-****

Email: kvtgjv@r.postjobfree.com

HIGHLIGHTS OF QUALIFICATIONS

• Over 5 years laboratory experience in pharmaceutical manufacturing

• Experienced in sample testing, data analysis, result documentation, and report creating

• Profound working knowledge of wet chemistry and analytical instruments (i.e. HPLC, GC, Auto-Dissolution, FTIR, UV Spectrophotometer, and Karl Fisher Apparatus)

• Practiced in analytical method development, validation, and transfer

• Experienced with calibration and maintenance of laboratory instruments

• Sound knowledge of USP/BP/EP, SOPs, cGMPs/cGLPs, and FDA/ICH guidelines

• Proficient with Chemistation, Empower, LIMS and MS Word, Excel, PowerPoint

• Self-motivated individual with strong work ethic, and able to work independently within a team environment

RELEVANT EXPERIENCES

Chemist

Ben Venue Laboratories, Bedford, OH USA 2008 to 2012

• Utilized analytical instruments, such as HPLC, uPLC, IC, GC, to test finished products and stability samples for assay and impurities according to USP/BP/EP, customer test procedures and in-house method

• Processed and reported data by Empower and LIMS, reviewed and checked data in compliance with SOPs, cGMPs and the established specifications

• Reviewed analytical reports and performed non-conformances investigations to ensure the discrepancies were resolved

• Performed analytical method development, optimization, and validation for drug substances and pharmaceutical products

• Written/revised technical documents including draft method, lab procedures, and method validation protocols/report under FDA, ICH guidelines

Chemist

Abbott Laboratory, North Chicago, IL USA 2007 to 2008

• Tested physical characteristics of finished products and stability samples according to USP/BP/EP, Abbott’s SOPs and STMs

• Performed chemical analysis for active components, related compounds, and/or impurities of drug products by HPLC and GC

• Conducted calibration for laboratory instruments, such as KF auto-titrator, balances, and pH meter

• Documented result, analyzed data, created technical report, and maintained database in compliance with GMPs/GLPs

Scientist

GMP Lab, PPD, Madison, WI, USA 2006 to 2007

• Created new analytical methods, enhanced existing methods, and transferred customer-provided methods

• Planned development guidelines and procedures that will best achieve a valid method in accordance with client predetermined requirements

• Took the analytical lead on assigned projects, identified and performed the required analytical tasks for method development

• Conducted sample preparation and analysis procedures to quantitatively measure active components, related compounds, and impurities in a variety of drug formulations from clients

Chemist

QC Department, KIK Custom Products, Toronto, Canada 2004 to 2006

• Performed testing and releasing during phase of production including incoming raw materials, process samples and finished bulk products

• Provided technical assistance in compounding departments for batch adjustments where required

• Provided sample analysis for cleaning validation on production process of new batch/products within set deadlines

• Documented all results in lab notebooks and in compliance with SOPs and GMP/GLP

• Conducted calibration and maintenance of laboratory instruments, such as HPLC, GC, UV, FT-IR, KF auto-titrator, balances, pH meter, and viscometer

EDUCATION

M. Sc. Chemistry

Department of Chemistry, York University, Canada 2004

TRAINING

Ben Venue Laboratories 2011

• Conducted Empower, LIMS, and other required training according to the laboratory

GMP Lab, PPD 2007

• Completed HPLC application/method development, and technical writing training

KIK Custom Products 2006

• Achieved cGMPs, SOPs, Chemistation, work safety, and documentation training



Contact this candidate