Training Medical

JIMMY CHEN

*** *** ***** ***, ***** ***, Toronto, ON M2J 2T7

***********@*******.***,416-***-****

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OBJECTIVE: To work in a R&D-oriented capacity where I can use my

Chemistry background and experience in the pharmaceutical

industry

HIGHLIGHTS:

. Experience at analytical method development and validation

. Hands on expertise in: HPLC/UV/DAD/ELSD/fluorescence/MS, SEC, IC, CE,

GC, Dissolution, TLC, KF, UV-Vis, IR, Melting Point, Optic Rotation,

Elemental Analysis,DSC, TGA, Microscope and wet chemistry techniques

etc

. Experience with analysis of chiral and achiral compounds

. Sound knowledge of analytical, organic, physical chemistry etc,

specialized at theoretical and practical knowledge of chromatography

and spectrograph

. Strong understanding of SOPs and cGMPs, FDA, ICH,USP, EP

WORK HISTORY:

Chemist III, Analytical R&D (2007-2011)

Gorbec Pharmaceutical Services, Inc, Durham, NC, US

. Developed stability-indicating method for raw material &

formulation(incd: complex formulations and tough topical formulations)

. Developed GC method for residual and deformulation

. Worked out validation protocol for raw material, formulation and

residual

. Performed method validation

. Participated in cleaning validation

. Wrote validation report

. Reviewed validation protocol and report

. Performed composite samples analysis

. Performed stability analysis

. Transferred the developed method to QC

. Supported formulation R&D for its formulation and deformulation

. Contributed to trouble-shooting projects

. Offered trouble-shooting to instruments

Packager, Pharmaceutical Packaging Line (2005-2006)

Patheon Pharmaceuticals, Whitby, ON-Spherion Staffing Solution, Whitby,

ON, Canada

. Packaged pharmaceutical products

. Performed in process control and in process check

. Guaranteed labeling and printing of Lot No. and Expired Date was right

. Calculated stuff accountability and be sure it within prescribed

tolerance

. Filled Manufacturing Instruction and clean up record

Chemist, QC, (1997-2004)

Bayer (Sichuan) Animal Health Co. Ltd., Chengdu, China

. Validated analysis methods from headquarter and performed the

following test:

. Identification by IR, TLC, HPLC and UV etc

. Acidity/basicity/pH by pH-meter or titration etc

. Heavy Metal test, Arsenic, Chloride, Loss on Drying, Residue on

Ignition

. Related Substance or impurities by HPLC, TLC or Colorimetric solution

etc

. Dissolution, Content Uniformity by UV, HPLC

. Assay by UV, HPLC or titration

Chemist, QC, (1995-1996)

Qili Pharmaceutical Company, Chengdu, China

. Investigated and validated analysis methods for Tinidazole Injection

. Performed product stability test

. Analyzed raw materials, semi-finished products and finished products

. Calibrated pipettes, burettes, dissolution

. Managed stock of consumable stuff

Chemist (1988-1994)

Sichuan Provincial Inst. For Drug Control, Chengdu, China

. Validated and audited specifications and methods of new drug substance

and products

. Analyzed raw materials and finished products

. Provided training to staff from city inst. for drugs control

EDUCATION & TRAINING:

. Bachelor of Pharmacy

West China University of Medical Sciences, Chengdu, China

. Master of Biomaterials

Chongqing University of Medical Sciences, Chongqing, China

. Training at Management Technique, Leadership, Communication &

Cooperation, Responsible Care

Bayer (China) Holding Inc., Beijing, China

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