Quality Control Manufacturing

KIEU-CHINH LE

HTTP://WWW.LINKEDIN.COM/PUB/KIEU-CHINH-LE/15/466/974/ CELL: 610-***-****

EMAIL: *************@*****.***

SUMMARY

Dedicated scientist with over twelve years of professional experience in the pharmaceutical industry, drug

discovery, research and manufacturing.Quick-learner, well-organized, hard-working and self-motivated

individual with proven ability to effectively multi-task.Thorough knowledge of Good Laboratory

Practices (GLP) and Good Manufacturing Practices (GMP), and cell culture aseptic techniques.

• Different virus assays: Herpes Simplex Viruses (HSV-1 & HSV-2), and Vaccinia.

• Hands-on experience with Flow Cytometer FC500, AcT 5 Diff Hematology Analyzer, Cedex

(Innovatis AG), Nova Bioanalyser, ViCell, Clonepix FLSoft agar, Liquidator® 96, Octet ® RED96,

Protein A, disposable and stainless steel bioreactors, nephelometer, gel electrophoresis of protein

and nucleic acids, Assays, Bioassays, ELISA, Immunoassay,qPCR, Southern and Northern Blott

analysis, AmaxaNucleofector.

• Environmental Monitoring GMP production facility.

• Cell culture methods including CHO, PerC6, NS/O, Myeloma cell lines, etc…

• Perform transfections, single-cell cloning and cell banking.

• Hands-on experience in the operation and maintenance of cell culture bioreactors.

PROFESSIONAL EXPERIENCE

WEST CHESTER UNIVERSITY, West Chester, PA 2013 - Present

Research Associate, Microbiology/Virology/Immunology Laboratory

• Production and purification of mice polyclonal and monoclonal antibodies against Herpes

Simplex Virus type 2 and Vaccinia Virus Glycoproteins.

• Perform samples for Genetic Analysis, Ex: Southern, Northern, cDNA, and qPCR

BRISTOL-MYERS SQUIBB Inc., Bloomsbury, NJ 2012 - 2013

Research Scientist- Consultant, Cell Molecular Biology

• Performed transfection, amplification, and single-cell cloning of cell lines for the isolation and

selection of stable high antibody-expressing clones. Performed routine titer evaluationsusing

Octet. Performed the cryopreservation of cell banks.

• Performed the cryopreservation of cell banks.

• Performed 6wks and 12 wks stability studies on RCB’s.

• Prepared samples for Genetic Analysis, Ex: Southern, Northern, cDNA, and qPCR.

• Initiated training using the TAP AmbrMicrobioractor.

DENDREON INC., Morris Plains, NJ 2011 - 2011

Associate II, BioAssay Quality Control

• Performed processing and final product testing of Dendreon products according to departmental

SOP’s. (Flow Cytometer, ELISA, Complete Blood Count, and Viability).

• Examined products for infectious components virus and bacteria using Gram Stain and Endotoxin

bioassays.

• Received and maintained test samples, reagents and reference standards according to

GMP.

• Performed gram staining procedures to evaluate growth in media.

MEDAREX INC., (Wholly-Owned of Bristol-Myers Squibb), Bloomsbury, NJ 2005 - 2010

Associate Scientist II, Cell Line Development

• Performed subcloning of cells for isolation and selection of stable high antibody-expressing clones

in protein-free and animal component-free media.

• Performed media development and cell growth studies in batch and fed-batch mode.

• Generated Research Cell Bank (RCB), Master Cell Bank (MCB), and Master Working Cell Bank

(MWCB).

• Cultured and prepared samples for full characterization of cell banks, including preparationfor

shipment and tracking of test results.

• Conducted12 weeks stability studies of MCB and MWCB, as well as preparing technical reports

and memos.Reviewed and generated SOPs and batch records.

• Monitored laboratory equipment for cGMP compliance.

• Developedhigh density cell banks to reduce clinical manufacture time line.

• Operated stir tank, wave and perfusion bioreactors.

• Maintained and propagated cell lines using 1-50L scale cell culture: t-flask, shake flask, spinner

flask, disposables, and perfusion bioreactors.

• Performed routine Environmental Monitoring GMP production facility when the MCB or WCB

was performed (air, surfaces, and personnel using RODAC plates, TSA plates, RCS HF and Met

One methods).

CENTOCOR INC. (JOHNSON & JOHNSON), Malvern, PA 2002 - 2005

Assistant Scientist, Technology Transfer and Project Planning/Cell Banking

• Performed GLP and GMP cryo-preserve mammalian cells using aseptic techniques (adherent and

suspension cells), and maintained tissue cell culture.

• Conducted 12 weeks stability studies of DCB, MCB, and WCB.

• Prepared technical reports and memos.

• Created Certificate of Analysis (C of A) for MCB and WCB.

• Performed routine Environmental Monitoring GMP production facility (air, surfaces, and personnel

using RODAC plates, TSA plates, RCS HF and Met One methods).

• Performed daily monitoring of non-GMP and GMP liquid nitrogen freezers and other laboratory

equipment.

• Inventoried and ordered lab supplies.

• Reviewed and entered final test results into the MS Access database.

• Trained new employees to work in GMP lab environment.

PROFESSIONAL DEVELOPMENT

• American Red Cross: Standard First Aid, Bloodborne Pathogens, and AED/CPR, Bloomsbury, NJ.

June 2009.

• Certification in the Requirements of the U.S. Department of Transportation, Title 49 CFR and

International Civil Aviation Organization (ICAO). Malvern, PA., May 2006.

• Certification in Current Good Laboratory Practices and Current Good Manufacturing Practices- A

Basis Primer, Malvern, PA., September 2005.

• Certification in the Requirements of the Code of Federal Regulations, Title 49 and the IATA

Dangerous Goods Regulations, Malvern, PA., September 2005.

• Certification in BioGMP Training Seminar for the Biotechnology and Pharmaceutical Industries,

Malvern, PA., August 2004.

EDUCATION

Master Degree Candidate in Biology, West Chester University, West Chester, PA 2003 - 2004

Bachelor of Arts, West Chester University, West Chester, PA 2001

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