[Next-Generation Sequencing Book]
  • [Photo] Jim Davidson • July 8, 2005

    BACKGROUND

    Individual will be part of a multi-site team responsible for the business analysis needs of the global Regulated Laboratories line within IT- Technical Systems. The scope of the Regulated Laboratories line includes Preclinical and Clinical Development Sciences, Biopharmaceutical Process Development, Pharmaceutical Sciences and Technology and Quality Control laboratories at all Lab sites.

    RESPONSIBILITIES:
    As a member of the group individual will assist in the rigorous analysis of and provide recommendations for strategic projects centered on the utilization of information technology within the regulated laboratories.

    Areas of focus can include:
    • Introduction and utilization of new technologies (e.g., SDMS, LIMS, laboratory automation and electronic record keeping) to improve productivity and regulatory compliance within the laboratories
    • Development of the existing IT infrastructure to provide advanced information management and decision support capabilities within the laboratories and its touch points within the company
    • Enhancing the cost-effectiveness and efficiency of the support capabilities of IT-Technical Systems

    REQUIREMENTS

    • 5+ years of experience in the biotechnology or pharmaceutical industry
    • Strong understanding of GxPs, 21 CFR Part 11 and validation requirements of computer systems in regulated laboratories
    • Deep knowledge of laboratory and scientific processes used in drug development
    • Knowledge of current trends and competitive positioning within the drug development industry

    PREFERENCES

    • Knowledge and understanding of key tools relevant to the regulated laboratory work place such as enterprise laboratory data management systems, instrumentation data systems and analytical tools as well as SDLC methodologies
    • Expert process modeling and quantitative/semi-quantitative analysis capabilities
    • Ability to define and lead "Concept and Planning" stages of mid-to large-scale projects and ensure successful hand-off to the build and implement teams.

    TERMS

    12 month contract

    LOCALE:
    Boston, MA

    COMPENSATION

    $50 to $70 hour

    HOW TO APPLY

    email jdavidson[at]grouptechinc.com

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