Gregory P. Email & Phone Number

Rockville, Md, Us

Silver Spring, Md

Regulatory Review Experience:CGMP Lead Facilities Inspector for PA and PL Inspections-Perform site audits to determine whether operations follow CGMP and 21CFR Guidelines.-Review manufacturing processes and documentation including SOPS, deviations, and CAPAs. -Interview manufacturing personnel and management.-Provide feedback to management and personnel regarding any deficiencies or observations. -Write inspection reports to provide FDA management with overall facility compliance. Product Reviewer/Chair for BLA, PMA, NDA, 510K, and CBE30 manufacturing supplements.-Evaluate facility design, operation, manufacturing/testing procedures, and compliance with CGMPs.-Review/evaluate submissions to determine whether manufacturing changes are scientifically justifiable.-Evaluate data for deficiencies. -Write information requests when deficiencies are determined.-Write memos for approval/denial based on full review.-Follow all mandated and internal timeframes.

Washington D.C. Metro Area

Directed, designed, and taught General Microbiology lecture and laboratory courses for Fall Semester 2013.

Aurora, Co

Research Project: Development of cholera holotoxin-like chimeras and cholera toxin B subunit chimeras for vaccine development against Vibrio cholerae, uropathogenic Escherichia coli (UPEC), and Neisseria gonorrhoeae.-Designed and developed experimental procedures and immunization studies.-Developed novel recombinant expression constructs and methodology for high-level recombinant expression of cholera holotoxin-like chimeras and cholera toxin B subunit chimeras in E. coli. -Developed novel purification strategies for high-throughput, high yield of vaccine CTB-based chimeras using IMAC and IEX. -Immunized mice to determine immunogenicity/protective efficacy of CTB-based chimeras. -Developed the infant mouse model of cholera to determine protective efficacy of vaccine antigens. -Compiled and analyzed data.-Statistical analysis conducted using Prism GraphPad software.-Prepared and wrote published manuscripts.

Richmond, Va

Dissertation Research: Immunogenicity of the gonococcal transferrin binding proteins.-Designed and developed all experimental procedures and studies.-Expressed recombinant TbpA, TbpB, CTB, and CTB holotoxin-like chimeras in E. coli.-Purified antigens using combinations of IMAC, IEX, and SEC.-Immunized mice with recombinant antigens and collected blood and vaginal washes to determine vaccine immunogenicity.-Developed quantitative ELISA to determine antigen-specific antibody concentrations in sera and vaginal washes.-Developed serum bactericidal assays and growth inhibitory assays as a measure of in vitro vaccine efficacy.-Analyzed human sera and secretion samples from gonorrhea patients for the presence of anti-transferrin binding protein antibodies using quantitative ELISA.-Compiled and analyzed data. -Statistical analysis was performed using NCSS 2000/Pass 2000 statistics software.-Prepared and wrote published manuscripts.

Seattle, Wa

Research Project: Vaccine development against leishmaniasis-Expressed and purified recombinant Leishmania proteins for vaccine development. -Purified antigens using affinity and ion-exchange chromatography.-Operated HPLC and FPLC purifiers.-Analyzed vaccine antigens using SDS-PAGE, BCA, and LAL endotoxin assays.

Seattle, Wa

Research Project: Analysis of regulatory binding sites within the interferon-γ promoter.-Developed and created IFN-gamma promoter/reporter plasmids. -Maintained cell cultures using Jurkat T cells and primary murine splenocytes. -Transiently transfected culture cells to determine regulatory elements essential for IFN-gamma production using beta-galactosidase and luciferase reporter assays.

Albuquerque, Nm

Research Project: Development of DNA vaccines against M. tuberculosis-Immunized mice with genomic libraries obtained from M. tuberculosis. -Challenged immunized mice with M. tuberculosis as a method to screen for possible protective antigens.

Seattle Wa

Research Projects: Wound healing studies in genetically diabetic mice and the in vivo effects of recombinant thrombopoietin in myelosuppressed mice.-Analyzed the effects of recombinant human platelet-derived growth factor and recombinant human basic fibroblast growth factor in wound closure of genetically diabetic mice.-Analyzed recombinant human thromobpoietin in myelosuppressed mice for hematopoietic recovery.

Doctor Of Philosophy (Phd), Microbiology And Immunology

Bachelor Of Science (Bs), Microbiology, General

Bachelor Of Science (Bs), Speech And Hearing Sciences