Your Name
Summary
Accomplished leader in gene and cell therapy with demonstrated success translating innovative concepts into robust clinical programs. Expert in ex vivo cell manipulation, gene system design, viral and non-viral gene modification, process optimization, analytical development and CMC supporting the product development lifecycle from concept to clinic.
Overview
10
10
years of professional experience
Work History
Sr. Director > Executive Director Analytical Development
Intrexon Corporation
City
03.2013 - 08.2016
- Led development of CAR-T programs with specific focus on CMC and analytical development. Worked directly with CMC director to oversee the selection and day to day progress of technology transfer, process development and analytical at CROs and CMOs.
- Conceptualized and oversaw strategy related to CMC, non-clinical and analytical, authored portions of module 2, 3 and 4 of the CTD to support IND filings.
- Cross-functional management of all aspects of product development: Concept development, market analysis, program management, resource allocation, gene design and construction, cell biology and gene delivery, assay development, in vitro/in vivo POC, manufacturing process development, CMC, regulatory strategy, authoring regulatory filings.
- Led several non-CAR-T gene and cell therapy programs using genetically modified cells (Fbrobalsts, MSCs) or viral vectors (Ad5, AAV) to deliver therapeutic benefit.
- Managed several support laboratories providing cloning, LCMS, biochemical assay, process development and laboratory automation support to the internal teams.
Manager > Director > Senior Director, Analytical Development and Screening Ops
Intrexon Corporation
City
08.2009 - 03.2013
- Led diverse team of scientists supporting the analytical development and screening phases of several cell and gene therapy programs targeting Melanoma, A1AT deficiency, Duchenne Muscular Dystrophy, Fabry Disease, Krabbe Disease, Friedreich's Ataxia and Hemophilia.
- Oversaw project proposals, technical feasibility assessment, project plan development, project execution and generation of high quality reports for partners, management and business development.
- Successfully supported multiple diverse projects under stringent timelines and tight budgets.
- Interfaced with partners and internal leadership to ensure optimal project performance and foster collaboration.
- Implemented high-throughput laboratory automation approaches focusing on assay miniaturization, Hamilton and Biomek robotics and establishment of bioinformatics and data analysis pipelines.
- Conceptualized and implemented system for mining of experimental data to better understand the role of natural and synthetic regulatory elements in driving gene expression from engineered expression cassettes.
Scientist > Manager, Cell and Bioassay Operations
Intrexon Corporation
City
04.2008 - 08.2009
- Developed high-throughput plasmid DNA screening platform to support assessment of naturally occurring and synthetic gene regulatory elements.
- Established laboratory processes including cell culture, plasmid DNA transfection, biomaterial collection and analytical assessment.
- Managed the miniaturization of the processes enabling incorporation of laboratory automation such as Biomek and Hamilton robotics.
- Coordinated cross-functional team to develop required LIMS. applications to track sample movement throughout the analytical process and associate analytical data with sample lineage.
- Established data reduction
and analysis strategies and incorporated data visualization tool Tibco
Spotfire to enhance analytical output and
throughput
Worked with the bioinformatics
team to enrich the database structures to optimize the association of
genetic context to analytical outcome, which
led to exponential improvements in machine learning
algorithms.
Associate Scientist > Manager, Histopathology and Tissue Shared Resource
Lombardi Comprehensive Cancer Center-Georgetown University
City
03.2006 - 04.2008
- Developed and implemented laboratory operations and processes that streamlined sample processing, experimental setup, data analytics, reporting and billing.
- Managed the day-to-day activities of the histology operation including project portfolio management, quality control, scheduling, maintenance, billing and managing stakeholder interactions.
- Supervised a total of 8 scientists and provided operational, technical and scientific direction to teams working with molecular diagnostics assays (Affymetrix gene-chip, qPCR, ELISA, Western, Immunohistochemistry, Immunofluorescence).
- Oversaw microscopy systems for shared use within LCCC: Compound-fluorescent, inverted- fluorescent, laser-capture, gross-dissection, HistoRx. Utilized Image Pro Plus and ImageJ software for scripted image analysis and data capture.
Education
Master of Arts - Biopsychology/Neuroscience-Thesis
George Mason University
2007
Bachelor of Science - Biopsychology
George Mason University
2004
Skills
- Leader in cell and gene therapy development for 8 years
- Expertise in clinically relevant gene delivery technologies and cell types (T-cells, MSCs, Fibroblasts)
- Led development of CAR-T programs from research to preclinical development and IND
- Experienced with CAR-T program scale-up, CMC and analytical development
- Track record of success translating programs to the clinic
- Broad range of experience from early stage discovery to phase 1-2 clinical trials
- Technical expertise including gene system design, GM-cell process optimization and analytical development
- Experienced manager and mentor helping to build the next generation of biotech leaders
- Strategic thinker, able to see the bigger picture and drive strategy to accomplish the mission
Accomplishments
- Led development of CAR-T programs against hematological malignancies from early research and POC to late stage preclinical assessment and IND in collaboration with a large research institution.
- Managed pipeline of several early research CAR-T programs focused on identification and development of novel target antigens, stalks, co-stimulatory domains and surface tags.
- Developed CMC programs for CAR-T products and managed technology transfer to CROs and CMOs.
- Authored sections of modules 2, 3 and 4 of the CTD to support IND filings.
- Led research program to develop and enhance tregs to prevent and treat GVHD following HSCT.
- Advanced several gene and cell therapy programs from early discovery to phase 1-2 clinical trials: Adenovirus-based immuno-therapy to treat melanoma, glioblastoma and breast carcinoma; Lentivirus-based fibroblast product targeting Recessive Dystrophic Epidermolysis Bullosa; AAV-based gene therapy product targeting wet AMD.
- Introduced novel gene delivery systems and provided subject matter expertise leading to incorporation of the technology into several therapeutic programs.
Timeline
Sr. Director > Executive Director Analytical Development
Intrexon Corporation
03.2013 - 08.2016
Manager > Director > Senior Director, Analytical Development and Screening Ops
Intrexon Corporation
08.2009 - 03.2013
Scientist > Manager, Cell and Bioassay Operations
Intrexon Corporation
04.2008 - 08.2009
Associate Scientist > Manager, Histopathology and Tissue Shared Resource
Lombardi Comprehensive Cancer Center-Georgetown University
03.2006 - 04.2008
Master of Arts - Biopsychology/Neuroscience-Thesis
George Mason University
Bachelor of Science - Biopsychology
George Mason University
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