John Purdon

Experience

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  Sanofi-aventis

  Jan 1987 - Sept 2007

  Technology Leader, Industrial Pharmaceutical Development

  Actively managed a group responsible for scale up and transfer of all new products into the KC site. This included early development work with Research to define the manufacturing technologies/design processes to be utilized at commercial scale, scale up, validation and commercial launch.Provided initial technical evaluation, process fit, mfg feasibility and primary costing for all new 3rd party business.Provided technical support for sub-contracted and third party manufacturing including responsibilities as primary Sanofi-Aventis liaison.Primary project leadership responsibilities for at least one transfer program, and secondary responsibility for approximately 4 other transfer programs. Secondary support includes development of all financials, capital and expense funding requests and tracking, protocol authoring and process design/engineering support.Preparation and/or review of documentation required for submission filing. Show less

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  Purdue Pharmaceutical

  Sept 2007 - May 2012

  Associate Director, Pharmaceutical Technology

  Responsibilities included management of transfer, scale up and late stage development for new products as well as technical support for currently marketed products.*Mentored multi-site process improvement team streamlining Pharm Tech Development handoff with Commercial production. *Implemented multi-disciplinary team approach for transfer of new products into the site.*Participated in the development of the Wilson Initiatives Network (WIN) teams, charged with identifying opportunities for significant site improvements (systems, procedures etc) and developing/implementing solutions. Show less

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  Sandoz

  May 2012 - May 2016

  Development and implementation of a robust process for root cause investigations and identification/implementation of CAPA actionsImplement tracking and trending of deviations to identify continuous improvement projects to address process opportunitiesIdentify and support implementation of process and systems changes to improve control and data archival during manufactureFacilitate development and governance of manufacturing teamsProvide technical process support to manufacturing Show less

  • Executive Director, Technical Operations

    Mar 2013 - May 2016

  • Director of Operations

    Dec 2012 - Mar 2013

  • Director, Production Support

    May 2012 - Dec 2012
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  Baxter International Inc. - Contract

  Feb 2017 - Aug 2019

  Senior Program Manager

  Responsible for overall management of multiple FDA remediation work streams to eliminate compliance issues, including manufacturing processes, GMP Systems, Critical Systems, Facilities and documentation control.Direct the activities of multiple project managers, schedulers and client plant personnel to define project scope, technical design, capital investment requirements, execution, qualification and documentation required for each work stream.

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  Purdon Consulting

  Apr 2019 - Mar 2021

  Managing Partner

  Providing engineering, project management and documentation services, primarily to the pharmaceutical industry.

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  Fresenius Kabi

  Sept 2019 - Jan 2021

  Project Manager

  Managing commissioning, qualification and validation of utilities and facilities for the Fresenius Kabi IV solution expansion project.

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  Purdon Honey Farms LLC

  Oct 2020 - Apr 2024

  Business Owner

  Providing pollination services to East coast growers.

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  Gilbane Building Company

  Feb 2021 - now

  MEP Project Manager

  Customer liaison for all construction projects on site. Responsible for Quality plan development and execution, system testing and turn over package documentation delivery to client. Provide GMP/Life Science training to both internal and external audiences.