Sr. Director ≫ Executive Director Analytical Development Resume Example Intrexon Corporation

SR. DIRECTOR > EXECUTIVE DIRECTOR ANALYTICAL DEVELOPMENT

Professional Overview

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.

Core Qualifications

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.

Experience

Sr. Director > Executive Director Analytical DevelopmentMar 2013 to Aug 2016
Intrexon Corporation － Germantown, MD

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 OpsAug 2009 to Mar 2013
Intrexon Corporation － Germantown, MD

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 OperationsApr 2008 to Aug 2009
Intrexon Corporation － Blacksburg, VA

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 ResourceMar 2006 to Apr 2008
Lombardi Comprehensive Cancer Center-Georgetown University － Washington DC

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.

Skills

Managerial: Personnel Motivation and Coaching, Team Building, Communication, Domain Knowledge, Organization, Leadership

Project Management: Project Management Applications (MS Project, MS SharePoint), Planning, Organization, Resource allocation, Budgeting, Scheduling, Risk Mitigation, Change Management, CRO/CMO Technology Transfer and Oversight, Contract Negotiation

Technical: Laboratory Process Optimization, Assay Design and Validation, Experimental Design and Execution, High-throughput Screening (Development, Validation and Implementation), Laboratory Automation (Biomek FX, Hamilton Star), Biochemical Assays, Plasmid-DNA Transfection, Viral transduction – AAV, LV, Adenovirus, Stable Cell Line Development - CHO & HEK, Small-scale Protein Production and Purification (E. coli, mammalian cells), Biological Process Development and Manufacturing Process Optimization, Technical Troubleshooting and Root Cause Analysis, Data Analytics (GraphPad Prism, Tibco Spotfire, Microsoft Excel)

Personal: Personal Accountability, Self-motivation, Critical Thinking, Positivity, Thoughtfulness, Efficiency, Process-mindedness, Ability to Drive to Results, Flexibility, Resiliency, Attentiveness to Detail, Ability to Foster Positive Interactions

Education

Master of Arts, Biopsychology/Neuroscience-Thesis2007George Mason University － Fairfax, VAAdvisor: Robert Smith PhD

Bachelor of Science, Biopsychology2004George Mason University － Fairfax, VABiopsychology

Thesis/Dissertation

Thesis: "Gestational cocaine exposure causes enduring changes in offspring dendritic morphology and lasting behavioral changes in rat." Utilized cutting-edge imaging, molecular and behavioral analyses to study the impact of stimulant exposure on the developing reward centers of the brain.

Publications

Park HU, Suy S, Danner M, Dailey V, Zhang Y, Li H, Hyduke DR, Collins BT, Gagnon G, Kallakury B, Kumar D, Brown ML, Fornace A, Dritschilo A, Collins SP. AMP-activated protein kinase promotes human prostate cancer cell growth and survival. Mol Cancer Ther. 2009 Apr;8(4):733-41. PubMed PMID: 19372545; PubMed Central PMCID: PMC2775041.

Wu K, Li A, Rao M, Liu M, Dailey V, Yang Y, Di Vizio D, Wang C, Lisanti MP,Sauter G, Russell RG, Cvekl A, Pestell RG. DACH1 is a cell fate determination factor that inhibits cyclin D1 and breast tumor growth. Mol Cell Biol. 2006 Oct;26(19):7116-29. PubMed PMID: 16980615; PubMed Central PMCID: PMC1592900.

McDonald CG, Dailey VK, Bergstrom HC, Wheeler TL, Eppolito AK, Smith LN, Smith RF. Periadolescent nicotine administration produces enduring changes in dendritic morphology of medium spiny neurons from nucleus accumbens. Neurosci Lett. 2005 Sep 9;385(2):163-7. PubMed PMID: 15955627.

Presentations

Dailey, VK., McDonald, CG., Bergstrom, HC., Brown, K & Smith, RF. Gestational cocaine exposure causes enduring changes in offspring dendritic morphology and lasting behavioral changes in rat. (2005) Society for Neuroscience. Washington, DC.

McDonald, CG., Dailey, VK. Periadolescent nicotine exposure causes lasting changes in dendritic morphology in rat ventral striatum. (2004) Society for Neuroscience. San Diego, CA.

Resume Overview

Companies Worked For:

Intrexon Corporation
Lombardi Comprehensive Cancer Center-Georgetown University

School Attended

George Mason University

Job Titles Held:

Sr. Director > Executive Director Analytical Development
Manager > Director > Senior Director, Analytical Development and Screening Ops
Scientist > Manager, Cell and Bioassay Operations
Associate Scientist > Manager, Histopathology and Tissue Shared Resource

Degrees

Master of Arts , Biopsychology/Neuroscience-Thesis 2007
Bachelor of Science , Biopsychology 2004

Sr. Director > Executive Director Analytical Development Resume Example

Resume Score: 90%

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