Andrew Hooper

various consulting and pharma development and manufacturing operations roles at Various
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Contact Information
us****@****om
(386) 825-5501
Location
San Diego, California, United States, US

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5.0

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Thomas Stineman

Andy and I worked together on a contract for a Cell therapy company in Fort Worth, Texas. Our work overlapped about 6 months or so. I was working on process and Andy was organizing Project Management as well as acting as a subject matter expert on a number of products that were going through relicensing. A pleasure to work with him, and it was interesting to see all that he brought to the company in terms of organizing people, projects, and principles of a number of complex biotherapeutics.

Miriam K. Franchini

Andy served as an interim project manager for two extremely complicated wound care projects I was also involved with at Smith and Nephew Biotherapeutics, and filled a badly needed gap. In spite of the complexity, Andy was on board quickly, and made a number of very useful suggestions based on his excellent background in operations management and tech transfers at much larger companies, such as Aventis/Sanofi-Aventis. Andy is an experienced professional, but also very nice to work with, and is used to dealing with big pharma budgets and timelines in a multicultural setting where drug product manufacturing sites are located in different countries. I would not hesitate to hire Andy as a consultant or permanent employee for any of these areas, but especially contract or pharma ops, which are the areas he likes best.

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Credentials

  • CPIM (inactive)
    APICS
  • Lean Six Sigma Black Belt (ICBB)
    Acuity Institute
  • SPC Trainer
    Dow
  • Tracelink Certified Administrator (DSCSA/FMD)
    TraceLink

Experience

    • Investment Management
    • 700 & Above Employee
    • various consulting and pharma development and manufacturing operations roles
      • 2007 - Present

      Consultant, Managing Consultant, Director of Operations, PM (Gov't contracts), Director of Commercial Mfg. Consultant, Managing Consultant, Director of Operations, PM (Gov't contracts), Director of Commercial Mfg.

    • United States
    • Biotechnology
    • Vice President, Manufacturing & Technical Services (CMC/Development)
      • 2006 - Dec 2007

      API/DP CMC development and manufacturing leadership, ensuring adherence to global due diligence best practices for small molecule synthetic pathway development and SME/CDMO/site selection; met all development milestones under budget, including new and greatly improved synthetic pathway development for both NCE assets. API/DP CMC development and manufacturing leadership, ensuring adherence to global due diligence best practices for small molecule synthetic pathway development and SME/CDMO/site selection; met all development milestones under budget, including new and greatly improved synthetic pathway development for both NCE assets.

    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Industrial Operations Executive Team member (8 sites) and Dir., N.A. Industrial Technologies
      • 2001 - 2004

      Member of the Executive Team responsible for North America Industrial Operations (NAIO): all functions, >3,000 employees across 8 US, Canada and PR sites.Responsible for on time new product launches: leadership for all new product Transfer, Scale-up and Validation technical project teams and Governance Committee Chairperson for same. Operations best practices development and integration, including quickchangeover and fast cycle time projects integration.Occasional acting head for NAIO.Business Transformation: Aventis Global Industrial Excellence Project core team member: benchmarking, site performance reviews and web-based performance tracking, leading 20 sub-teams and over 200 internal SMEs, ensuring successful roll-out to 25 global strategic manufacturing sites, followed by global, regional and site goals integration and continuous sharing of best practices between sites and regions globally.Regional capital budget planning and site network consolidation activities.Post M&A harmonization teams: ensuring synergistic harmonization of policies and ways of working between regions and functions.Aventis NA Regional strategy development; cascading to site level.Board Member, Consortium for the Advancement of Manufacturing of Pharmaceuticals (CAMP), with participation of Pfizer, Aventis and other PhRMA companies along with Purdue, Rutgers and other university PharmD programs, to develop advanced methods and practices targeting chemometrics method development and equipment integration for 100% parametric release of drug products during manufacturing rather than after.Sponsor for enterprise manufacturing process intelligence solutions to support "process signature" development, to help enable parametric release.Manufacturing Process Technologies regional multi-site responsibilities included fast detection and immediate response to all regional manufacturing process troubleshooting and related investigations. Show less

    • Head, North America Industrial Technology & Lead Technologies and Engineering Center
      • 1999 - 2001

      R&D Liaison, Tech Transfer, Scale-up and Validation Governance Committee Chair for NCE development Project Teams (PII to launch), responsible for ensuring robust process development and transfer/scale-up practices from team formation to launch along with 100% launch readiness on day of approval for all development projects launching out of manufacturing sites and CMOs in North America.

Education

  • Western University
    Bachelor of Science, Biology/Biological Sciences, General
    1974 - 1978

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