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

DIRECTOR > SR. DIRECTOR > EXECUTIVE DIRECTOR, ANALYTICAL DEVELOPMENT

Professional Overview

Experienced analytical development and laboratory leader with demonstrated success developing and validating analytical systems to support IND filings and early stage clinical trials. Focused on phase appropriate development strategies to ensure cost and time efficiencies to help accelerate the timeline to the clinic. In-depth understanding of all FDA, EMA and ICH guidance along with a strong background in project management and a focus on operational execution lead to a professional that can provide leadership, technical expertise and organizational efficiency.

Core Qualifications

Leader in analytical development for gene and cell therapy products for 8 years
10+ years of analytical lab management
Deep knowledge of FDA, EMA and ICH guidance related to method development and validation
Project management expertise
Technology transfer to CROs/CMOs
GLP/GMP experience

Domain expertise - ELISA, MSD, qPCR, LCMS, cell-based, ligand binding, immunogenicity
Strong manager and communicator
Strategic thinker that sees the bigger picture
Focus on business process optimization
Business acumen leading to desirable departmental P&Ls

Accomplishments

Advanced analytical programs to support 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.
Built advanced operational governance and quality systems leading to improved analytical development project quality and reducing turnaround times by half.
Improved the economics of internal analytical labs by implementing resource management software, defining optimized business processes and governance models, optimizing workload projection models and focusing on predictable and consistent improvements in the departmental P&Ls.
Implemented project management framework that served as the basis for the departmental PMO. Identified best practices, built templates and deployed enterprise software solution that led to marked improvement in productivity and project transparency.
Established and managed internal service labs focused on molecular cloning and high-throughput screening that made significant impact on the discovery of therapeutic targets and saved the company millions of dollars compared to outsourcing similar activities.

Experience

Director > Sr. Director > Executive Director, Analytical Development Mar 2011 to Aug 2016
Intrexon Corporation － Germantown, MD

Development of analytical strategies to support advancing cell therapy, gene therapy and biologic development from preclinical to phase 1-2 clinical trials.
Analytical method development and validation conforming to FDA, EMA and ICH guidance, critical reagent programs and supply chain management, CRO/CMO identification and oversight, technology transfer and GMP implementation, regulatory strategy development, authoring regulatory filings and cross-functional product development leadership.
Developed analytical labs specializing in development and validation of ELISA/MSD (PK, bio-marker and immunogenicity), qPCR (bio-distribution and gene expression), cell-based viral titer and bio-functional assays, HPLC and LCMS product characterization assays (MALDI-TOF/TOF, LCMS/MS, Nano/Microflow LC-qTOF/Orbitrap).
Directed analytical programs from research to support IND-enabling preclinical studies: CAR-T therapy for AML (preclinical); Lentivirus-based fibroblast cell therapy for Linear Scleroderma (preclinical); AAV-based gene therapy for Neuropathic Pain (preclinical); AAV-based gene therapy for Friedreich's ataxia (research); Plasmid DNA-based gene therapy for Heart Failure (research).
Identification and implementation of enterprise operational systems including: Electronic lab notebooks (Agilent ELN); Content management (Agilent ECM data/information archival); Document management (Veeva Vault); Project management (SharePoint/Project integration); Bioinformatics applications to support data analytics (Tibco Spotfire); DNA sequence editing (Geneious); DNA sequence archival (proprietary); Protein Engineering (BioLuminate, Discovery Studio, etc.).
Led cross-functional project teams focused on enhancement of business process workflows throughout the therapeutics department.
Managed personnel and provided mentorship and guidance to up and coming leaders in the field.

Manager > Director, Analytical Development and Screening Ops Sep 2009 to Mar 2011
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, Cell and Bioassay Operations Apr 2008 to Sep 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 Mar 2003 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-Thesis 2007 George Mason University － Fairfax, VA

Advisor: Robert Smith, PhD

Bachelor of Science, Biopsychology 2004 George Mason University － Fairfax, VA

Thesis

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.

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Director > Sr. Director > Executive Director, Analytical Development Resume Example

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