Nancy L. Chapman MS-IS, PMP

Nancy L. Chapman MS-IS, PMP

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  • Timeline

  • About me

    Project Management | Global Labeling | Drug Delivery | Quality Assurance | Computer Validation | Operations

  • Education

    • Stevens Institute of Technology

      -
      M.S. Information Systems
  • Experience

    • Pfizer Inc. (formally Wyeth Global Pharmaceuticals)

      Jul 1999 - Oct 2005

      Promoted to oversee construction of a data center expansion capital project including installation of all raised flooring, electrical, fire suppression and air conditioning systems.• Headed-up government agency data center inspection site readiness campaign. Evaluated site quality systems for traceability, accuracy and consistency to prepare the data center and related facility support systems to withstand regulatory scrutiny in the midst of a consent decree.• Recognized to lead Corporate Information Services Compliance and Food and Drug Administration audits of data center operations. Show less

      • Project Manager

        May 2004 - Oct 2005
      • Systems Validation Engineer

        Jul 1999 - May 2004
    • AMGEN Inc.

      Dec 2005 - Sept 2014

      Hand-selected to forecast, plan, schedule, assign and track over 600 global labeling projects to support Biologics License Application filings, new product launches, human factors engineering studies, regulatory requirement updates and manufacturing line changes for Asia Pacific, Australia, Canada, Latin America and United States regions while adhering to tight timelines. Supported evolocumab (AMG 145), Amgen’s PCSK9 antibody for dyslipidemia, drug delivery program for three parenteral presentations. Facilitated design reviews, cross-functional core team and supplier project management meetings; authored meeting minutes, tracked action items and maintained risk, issue and decision logs. Managed program capital and expense budgets, procurements, customer complaints and human factors engineering studies. Provided executive and project support within Global Clinical Supply Chain, Chemistry, Manufacturing & Controls (CMC), Global Operations Planning and Drug Product & Device Development. Communication work stream lead for Chemistry, Manufacturing & Controls (CMC) Excellence Program.

      • Sr. Associate Project Manager

        Jun 2013 - Sept 2014
      • Associate Project Manager

        Jan 2012 - Jun 2013
      • Administrative Coordinator

        Dec 2005 - Jan 2012
  • Licenses & Certifications

    • Project Management Professional (PMP)

      Project Management Institute
      Dec 2011
  • Honors & Awards

    • Awarded to Nancy L. Chapman MS-IS, PMP
      Best Tabletop Exercise Toast Masters International Sep 2013
    • Awarded to Nancy L. Chapman MS-IS, PMP
      Bravo Applause Award: Work in Teams Packaging Engineering & Labeling Management Sep 2013 Global labeling process improvement suggestion submission and implementation.
    • Awarded to Nancy L. Chapman MS-IS, PMP
      Bravo Acclaim Award: Delivers Results Drug Delivery PMO Senior Management Mar 2013 AMG 145 auto-injector drug delivery device clinical launch.
    • Awarded to Nancy L. Chapman MS-IS, PMP
      Bravo Applause Award: Work in Teams Excellence in Operations Review Committee Mar 2013 Excellence in Operations Submission (collaboration in pursuit of operational excellence).
    • Awarded to Nancy L. Chapman MS-IS, PMP
      Bravo Applause Award: Work in Teams Drug Delivery PMO Senior Management Mar 2013 Development phase completion of on-body drug delivery device.
    • Awarded to Nancy L. Chapman MS-IS, PMP
      Best Speech Award Toast Masters International Oct 2012
    • Awarded to Nancy L. Chapman MS-IS, PMP
      Bravo Acclaim Award: Compete Intensely and Win Global Strategic Sourcing Senior Management Jun 2012 OEM Statement of Work development into Master Service Agreement.
    • Awarded to Nancy L. Chapman MS-IS, PMP
      Bravo Applause Award: Compete Intensely and Win Drug Delivery PMO Management Jun 2012 CDA initiation in support of new design of automatic needle guard project.
    • Awarded to Nancy L. Chapman MS-IS, PMP
      Bravo Applause Award: Work in Teams Drug Delivery PMO Management Jun 2012 Support human factors engineering study for new design of automatic needle guard project.
    • Awarded to Nancy L. Chapman MS-IS, PMP
      Bravo Applause Award: Work in Teams Global Clinical Supply Chain Senior Management Dec 2010 Clinical Drug Supply System integration into SAP project.
    • Awarded to Nancy L. Chapman MS-IS, PMP
      Bravo Acclaim Award: Ensure Quality Chemistry, Manufacturing and Controls Senior Management Oct 2008 CMC Excellence Knowledge Map Revision and Distribution
    • Awarded to Nancy L. Chapman MS-IS, PMP
      Bravo Acclaim Award: Develops the Best Team Commercial Process Development Senior Management Sep 2008 Commercial Process Development catalyst session.
    • Awarded to Nancy L. Chapman MS-IS, PMP
      Bravo Acclaim Award: Work in Teams Chemistry, Manufacturing and Controls (CMC) Excellence Senior Management Apr 2008 Core BPO Workshops 4/2008, 8/2008 and 10/2008.
    • Awarded to Nancy L. Chapman MS-IS, PMP
      A Night Out Marketing Key Global Research for Automatic Needle Guard Project Dec 2006
    • Awarded to Nancy L. Chapman MS-IS, PMP
      Peak Performance Award: Device Organizational Assess Project Drug Product & Device Development Senior Management Sep 2006
  • Volunteer Experience

    • Vice President

      Issued by AC2PM Club at Amgen on Mar 2011
      AC2PM Club at AmgenAssociated with Nancy L. Chapman MS-IS, PMP