Linda Powers

Experience

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  QuintilesIMS

  Jun 1997 - Apr 1998

  Research Assistant

  Lab analyst for a pharmaceutical clinic. Responsibilities included labeling, processing, and shipping biological specimens, platelet aggregation analyses, and protocol preparation. Assisted phlebotomists as needed.

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  Ceva Biomune

  Apr 1998 - Apr 1999

  Laboratory Technician

  Lab analyst for an avian vaccine supplier. Responsibilities included the isolation, characterization, and preparation of viruses and bacteria for vaccine production. Lab duties included cell and tissue culture, titrations, viral passages, necropsy, media preparation, and sterile technique.

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  Sekisui XenoTech, LLC

  Apr 1999 - Apr 2007

  Scientist

  Project management of drug metabolism studies in the pharmaceutical industry. Started in the lab performing a variety of techniques and analyses including liver perfusion, isolation, culture, and cryopreservation of hepatocytes, microsome preparation, enzymatic activity assays, Western immunoblotting, and UV/Vis spectral, fluorescence and radiometric scintillation analysis. Moved into a project management role which included responsibilities such as designing, scheduling and conducting studies, data processing and review, report compilation and review, client relations, and software validation. Developed and optimized novel enzymatic activity assays. Improved efficiencies within the department and company. Supervised a team of 7-10 individuals. Show less

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  Worldwide Clinical Trials

  May 2007 - now

  • Manage system life cycle for clinical applications• Engage business owners, system owners and users to ensure applications meet business requirements• Manage system configuration and functional testing• Provide system support• Provide technical expertise and training• Ensure validation compliance and industry best practices Administer a variety of applications including TrackWise, Watson, Biovia, NuGenesis, and Salesforce. Responsibilities are everything from the basics of access control to configuring and developing new projects. Data visualization includes Crystal Reports, Pipeline Pilot, and Tableau. System administrator for multiple applications used in the pharmaceutical industry. Participate in upgrades and validation of GxP compliant software. In addition to serving as Project Director, also supervised a team of 10-15 individuals. Improved efficiencies within the department and company. Oversaw approximately 200 projects annually. Project manager of validation studies for the pharmaceutical industry. This included client interface, proposal review, scheduling, data review and interpretation, troubleshooting, and report preparation and review. Worked with multiple departments (scientific, administration, marketing) to see projects to completion.

  • Manager, Early Phase Clinical Applications

    Feb 2023 - now

  • Senior IT Applications Administrator

    Jan 2019 - Feb 2023

  • IT Applications Administrator

    Feb 2015 - Dec 2018

  • Validation Team Leader

    Mar 2008 - Feb 2015

  • Project Director

    May 2007 - Mar 2008