08/21/09
Terry Shum
Baltimore, MD
Email: r1346@bio-link.org
Date Available:
within two weeks
Location Desired:
Baltimore
Objective:
To find a quality assurance or research associate position that would best utilize my auditing skills, knowledge of GXP's, cell culture experience, and other laboratory skills.
Education:
MS Physiology/ Neuroscience
BA Biology/ Psychology
Biotechnology Skills:
• Guava, FACS, SDS-PAGE, ELISA, Western blotting, mini- and Maxi-preps, immunohistochemistry, and protein assays
• Cell culture techniques involving various mammalian and human cell types
• Stable protein expression in mammalian and human cell lines utilizing various expression systems
• Molecular biology techniques including RNA isolation, PCR, gel electrophoresis, vector modification, and plasmid preps
• Assay development and implementation
• Experience in fluorescence microscopy and immunodetection
Work Experience:
June 2008 â€" June 2009
Quality Associate, Osiris Therapeutics, Baltimore, MD
• Provided QA review of all QC data needed to support lot release, stability testing, and research studies
• Promoted to head up Quality review of all QC data generated from ARS study funded by DOD
• Responsible for Quality review of all QC data generated to support modified QC testing developed for ARS study
• Revised protocols and batch records in accordance to current GDP/GLP/GMP
• Reviewed reports for GDP/GLP/GMP, prepared signed QA summary of findings, and provided QA signature upon finalization of reports
• Assisted in maintenance of training records necessary for establishment of training database
• Reviewed all data for FACS method development report; report summarized data supporting the implementation of new FACS method used in lot release testing
• Edited FACS method development report
May 2006 â€" June 2008
Research Associate, Osiris Therapeutics, Baltimore, MD
• Involved in the QC audit of all EM (environmental monitoring) paperwork
• Performed the internal audit of clinical data for GVHD trials; findings resulted in approval of procedural changes at clinical sites
• Involved in internal audit of Process Development and Manufacturing departments in preparation for FDA visit
• Participated in the planning and implementation of raw material testing
• Maintained cultures of human MSCs in the Process Development department
• Worked on validation of the hMSC culture process and improving and streamlining the process in order to ensure consistency of the hMSC cultures
• Participated in revising and writing of protocols, SOPs and data reports
• Trained relevant staff on revised documents
• Designed studies for Process Challenge experiments needed to support BLA filing; also wrote study protocols, provided necessary training, and wrote study reports
• Revised all of the SOPs and BPRs inherent to the process transfer of hMSC manufacturing to our CMO (contract manufacturing organization)
• Trained and participated in FACS validation study
• Drafted the process validation protocols for hMSC manufacturing
• Organized and maintained laboratory supplies and reagents used in the lab
• Assisted in weekly monitoring of radiation levels in adjacent laboratory
• Maintained cultures of murine, porcine, and canine MSCs used for various studies to investigate the therapeutic uses of mesenchymal stem cells
June 2001-July 2004
Graduate Research Assistant, University of Maryland, Baltimore, MD
• Utilized a variety of lab protocols, such as ELISA, tissue culture, Western blotting, protein assays, gel electrophoresis, PCR, microscopy and immunohistochemistry, during the research of Parkinson's Disease, cardiac hypertrophy, breast cancer, and sexual differentiation
• Analyzed and organized data for lab presentations
• Assisted in planning of experiments and experimental design
• Used internet to retrieve research papers relevant to projects in laboratory
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