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C HLOE W OOD , MS & MBA 6125 14 th Street #303 Washington, DC (202) 368-0036 [email protected] Q UALIFICATION S UMMARY My 15-year career in Biotechnology has covered research and development (R&D), regulated environments, and product development. In my most recent position, I was a member of a project team responsible for in-vitro diagnostic (IVD) product development and 510K applications for the FDA. My personal responsibilities involved performing risk assessments, troubleshooting design problems, and managing daily activities within the laboratory. In addition, I created a pilot laboratory for the production of hybridoma and monoclonal antibodies; this included designing the standard experiment procedures for the laboratory, writing the SOP’s, training staff, assigning daily tasks and projecting costs. I would also like to point out that I have an extensive technical skill set that includes immunologic assays, molecular biology, tissue culture, monoclonal antibody development, vaccine development, laboratory management, budget monitoring, and personnel training. AREAS OF EXPERTISE GLP & GMP regulated environments Budget monitoring and cost projections Scientific and technical writing Microsoft Office Suite SoftMax Pro Assay development, troubleshooting, and validation Data analysis, management, and presentation Experimental design Mammalian cell culture and hybridoma production Antibody and protein purification PROFESSIONAL EXPERIENCE Wellstat Diagnostics, Gaithersburg, MD 2010 - 2015 Product Development Position : Associate Scientist involved in developing immunoassays to be used as point of care (POC) diagnostic and therapeutic products (electrochemiluminescent format) Key member of a product development team that was responsible for FDA 510K applications

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Page 1: Chloe Wood Resume.docx

CHLOE WOOD, MS & MBA6125 14th Street #303 Washington, DC (202) 368-0036 [email protected]

QUALIFICATION SUMMARY

My 15-year career in Biotechnology has covered research and development (R&D), regulated environments, and product development. In my most recent position, I was a member of a project team responsible for in-vitro diagnostic (IVD) product development and 510K applications for the FDA. My personal responsibilities involved performing risk assessments, troubleshooting design problems, and managing daily activities within the laboratory. In addition, I created a pilot laboratory for the production of hybridoma and monoclonal antibodies; this included designing the standard experiment procedures for the laboratory, writing the SOP’s, training staff, assigning daily tasks and projecting costs. I would also like to point out that I have an extensive technical skill set that includes immunologic assays, molecular biology, tissue culture, monoclonal antibody development, vaccine development, laboratory management, budget monitoring, and personnel training.

AREAS OF EXPERTISE

GLP & GMP regulated environments Budget monitoring and cost projections Scientific and technical writing Microsoft Office Suite SoftMax Pro

Assay development, troubleshooting, and validation

Data analysis, management, and presentation

Experimental design Mammalian cell culture and hybridoma

production Antibody and protein purification

PROFESSIONAL EXPERIENCE

Wellstat Diagnostics, Gaithersburg, MD 2010 - 2015Product DevelopmentPosition: Associate Scientist involved in developing immunoassays to be used as point of care (POC) diagnostic and therapeutic products (electrochemiluminescent format) Key member of a product development team that was responsible for FDA 510K

applications Organized the daily activity of a team of scientist on multiple development projects Trained and assigned daily tasks to junior members of the project development team Performed qualification, robustness, and verification on biologic and small molecule

detection and quantitation immunoassays Identified design problems in R&D assays and resolved these issues during the

product development process Understand of the process of transitioning assays from R&D to product development

and from product development to a CSO or manufacturing facility

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CHLOE WOOD Phone: (202) 368-0036 ♦0036 ♦ Page 2

Collaborated with different functional groups within a company (QC, QA, Manufacturing, Technical Transfer, CSO, and Purchasing)

Made project initiation/rejection recommendations to upper management based on product feasibility and risk assessments

Created a pilot hybridoma and monoclonal antibody laboratory Data management, analysis, and presentation Scientific and technical writing (SOP's, protocols, data summaries, research reports,

and deviations)

Clinical Research Management Inc., Silver Spring, MD2004 - 2010

Government Contractor at the Walter Reed Army Institute of Research, Department of Malaria Vaccine DevelopmentPosition: Senior Research Associate in a Contract Service Organization (CSO) focused on the evaluation of Phase I & II Clinical Trials for Malaria Vaccine Candidates Collaborated with clients to develop new GLP-compliant immunoassays (ELISA)

for clinical data production Managed potency testing to determine the effects of time and storage conditions

on vaccine efficacy Performed stability studies on clinical assays, clinical assay controls, and QC

samples Performed lot qualification of critical reagents used in various ELISA assays Oversaw personnel, monitored budgets, and procured supplies

Team Placement/ Biosearch (Government Contractor), Silver Spring, MD 2001- 2004

Government Contractor at the Walter Reed Army Institute of Research, Department of Malaria Vaccine DevelopmentPosition: Research Associate responsible for coordinating the day-to-day efforts of passive vaccine development against malaria using humanized monoclonal antibodies Harmonized the development activities of several research laboratories and

unified their efforts to produce a passive vaccine Participated in all stages of hybridoma production from antigen purification to

monoclonal antibody production and purification

University of Pittsburgh Medical Center, Pittsburgh, PA2000-2001

Department of Critical Care Medicine and Anesthesiology

Position: Research Technician III in a laboratory developing monoclonal antibodies against commonly used anesthetics

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CHLOE WOOD Phone: (202) 368-0036 ♦0036 ♦ Page 3

Participated in all stages of hybridoma creations and monoclonal antibody production

Performed general laboratory and equipment maintenance

HVL Inc., Pittsburgh, PA 1999-2000

Vitamin Company, Quality Control LaboratoryPosition: QC Associate that performed microbiology testing on company products Tested products (vitamins) for bacterial contamination and performed bacterial

identification on contaminated products

EDUCATION

Masters of Science in Biotechnology (MS), The Johns Hopkins University 2007 Masters of Business Administration (MBA), The Johns Hopkins University 2007 Bachelors of Science in Biological Studies (BS), The University of Pittsburgh 1999

PUBLICATIONS

Available on LinkedIn and upon request