Quality Control Process

Hands on experience with cGMP and GLP compliance:

Immunoassay and cell-based assay: Gel Electrophoresis, Protein quantification, ELISA, Western Blot, Dot blot, IP, FRET (fluorescence resonance energy transfer), Potency Assay, FACS, CTL (Cytotoxic T lymphocyte assay), and protein/antibody labeling

HPLC method: SEC & RP-HPLC (Millennium and ChemStation software)

Molecular biology: RNA extraction, DNA Cloning, PCR, RT-PCR, DNA sequencing,

Protein purification: Hybridoma cell production and monoclong antibodies purification, IEX, AC, IMAC

Trained and experienced in cGMP compliance, familiar with FDA guidelines and regulations

Work Experience

Ipsen, Milford, MA

Quality Control, Temp Oct. 2011

Participate assay validation, stability study and QC release testing for ELISA and Potency Assay

Genzyme, Framingham, MA

Quality Control Technical Service, Temp Aug. 2010-Oct. 2011

• Participate in assay qualification, and validation in cleaning validation project including Quantitation of residual Fabrazyme after equipment cleaning

• Participate in assay optimization, qualification, and validation for New Cerezyme Free Thiol quantitation

• Participate in Fabrazyme Deg Path study supporting Genzyme Biologics cleaning at 74 NYA

• Provide analytical support in the Myozyme Silver Stain SDS-PAGE Impurity Limit Test Assay

Agenus, Inc., Lexington, MA 1999-2006

Process and Analytical Technology, Senior Research Associate

Participated in process development of Heat Shock Protein based cancer vaccine.

Contributed to the discovery of a new mechanism (Personalized for each individual patient) for cancer vaccine

Assay development, optimization, qualification, and validation including

ELISA & Western Blot assays to quantify impurities (HCP, leachable, and other process/product-related impurities) in process intermediates and drug product

Fluorescence based binding assays for quantifying and monitoring protein in the purification process by FRET, and the Nucleic Acid quantitation in final product

Biological Assays included cell-based Potency assay and Testing enzymatic activity by RP-HPLC

Using SEC to identify the protein form and protein complexes

Determining the final product concentration and purity by RP-HPLC

Protein purification modification to improve the drug efficacy and production efficiency (IEX, AC, and IMAC)

Celldex Therapeutics, Inc., Needham, MA 1996-1999

R&D, Research Associate

Performed experiments studying HIV DNA and recombinant protein vaccination in animals

• Cloning and eukaryotic expression, Mass-scale DNA preparation, PCR, DNA sequencing

• Immunoassay and Cell-Based assay development, optimization, qualification: ELISA, Western Blot, IP, FACS, CTL

• Protein purification from bacteria, host cells, and animals including scale up

Education

Northeastern University, Boston, MA 2006-2010

Master of Science in Biotechnology (Concentrated on Analytical Biochemistry)

References:

Available upon request

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