Quality Control Years Experience

Lixuan Huang

** ***** ***, ******, ** *****

Tel: 781-***-****(C)( 781-***-**** (H) ( E-mail:

************@*******.***

Summary

. Hardworking, self motivated, passionate and self disciplined scientist

with more than 5 years experience in cGMP and cGLP environment.

. Sound understanding of chromatography chemistry in HPLC and GC; broad

experiences in applying basic scientific and statistical principle to

practices of dissolution for drug products.

. Multitasking in dealing with variety of projects for internal

department and contract lab.

. Proficient in analytical instruments such as HPLC, UV, FTIR, Karl-

Fisher titration, GC, TOC and basic web chemistry skill.

. Excellent in Microsoft excel, Microsoft word, Power point,

Chemstation, Millennium, PC1000, Turbochrom.

Experience

TEDOR PHARMA: Cumberland, RI

(CRO/CMO pharmaceutical company)

(Formerly known as Longwood Pharmaceutical Research Institute, Boston, MA)

Senior Research Scientist, 2003-

2012

Research Scientist, 2001-2003

. Performed routine analytical method development and validation for

various purposes based on HPLC and GC. Conducted assay, related

substance test for drug substances and drug products by using reverse

phase, normal phase, size exclusion and ion exchange chromatography

techniques.

. Issued Certificate of Analysis, Stability report and method transfer

to QC department.

. Complied with all aspects of cGMP, cGLP, CMC, Safety, DEA, ICH and

Environmental legislation.

. Provided high quality, on-time delivery analytical support on method

development, validation and stability test for the contract Lab.

. Conducted internal analytical test for formulation group including

fast, controlled released, extended released solid dosage, liquid and

aerosol.

. Validated method for Raw Material and Finished Product for NDA and

ANDA submission.

COPLEY PHARMACEUTICAL INC., Canton, Massachusetts

Validation Chemist, 1993

-2000

. Developed, validated and documented Assay, Related Substances, and

Dissolution and Cleaning methods in support of the ANDA submission.

. Performed analysis for in-process, finished and stability products for

the ANDA batches.

. Coordinated with the Formulation group to conduct deformulation of the

Brand and improvement of the Copley products.

. Performed quality control analysis for in-process, finished and

stability products including tablets, liquids, capsules and creams

using HPLC, GC, and dissolution systems in QC department.

Education

UNIVERSITY OF MASSACHUSETTS, Boston, MA

Master of Science, Biochemistry

UNIVERSITY OF SCIENCE AND TECHNOLOGY OF CHINA, China

Bachelor of Science, Analytical Chemistry

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