Katharina Gschwandtner

Katharina Gschwandtner

Research Associate

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  • Timeline

  • About me

    Director - Global Program Management (Plasma-Derived Therapies Business Unit) bei Takeda

  • Education

    • University of Applied Life Sciences, Krems, Austria

      2011 - 2013
      Master of Science (MSc) Regulatory Affairs

      Core Subjects: Marketing Authorization EU/ USA/ RoW, Life Cycle Management, Intellectual property rights, Medical product/ device regulationsMaster Thesis: The pandemic influenza vaccine licensing process – a comparison of health authority procedures and evaluation of harmonization requirements

    • University of Applied Life Sciences, Krems, Austria

      2005 - 2009
      Diplom Ingenieur (DI) Medical and Pharmaceutical Biotechnology

      Core Subjects: Medical and Pharmaceutical Bioprocess-Technology, Microbiology, Immunology, Molecular biology, Biochemistry Diploma Thesis: Influence of recombinant Wnt proteins on osteoblast differentiation of murine Embryonic Stem cells in serum free medium

  • Experience

    • Fraunhofer Institute for Cell Therapy and Immunology

      Jul 2008 - Jan 2009
      Research Associate

      Research work for Diploma Thesis to study the influence of recombinant Wnt proteins on osteoblast differentiation of murine Embryonic Stem cells in serum free mediumLab experience with PCR, ELISA, Cell Culturing, Cloning, SDS-PAGE-Gel, etc.

    • Baxter International Inc.

      Jul 2009 - Aug 2015

      Led/managed high-visibility "Baxter Top Project" (reported to investors) to develop, register and launch new biologic drug in U.S., EU and RoW (development of injectable therapy indicated for Primary Immune Deficiency, for subcutaneous self-admin by patients at home to significantly improve patient convenience and therapy compliance):Developed and maintain detailed launch timeline, project financial model, and management reporting - in charge of project planning and execution and process managementCoordinated inter-relationships between Phase III clinical trials in EU and U.S.; development of commercial scale manufacturing process; planning for CMC activities and regulatory filingsFacilitated Upper Management-level discussions and decisions on project strategy (budget/ timing/ scope)Project Management Excellence Award: Project Manager of the year (2014) Show less Working on 4 vaccine development programs (Seasonal/ Pandemic Influenza) from exploratory research through licensureGeneration and maintenance of integrated project plans and associated project documentation; set-up of project timelines and facilitation of scenario analyses; supporting global project managers in coordination of cross-functional project core teamsResponsibility for budgeting and controlling of R&D program spend; primary point of contact for external collaboration partners Show less

      • Project Manager - Program and Portfolio Management BioTherapeutics

        Jan 2014 - Aug 2015
      • Project Management Analyst - Program and Portfolio Management Vaccines

        Mar 2012 - Jan 2014
      • Project Management Associate - Program and Portfolio Management Vaccines

        Jul 2009 - Feb 2012
    • Baxalta

      Sept 2015 - Jun 2016
      Global Program Manager - Global Program Management Immunology
    • Shire

      Jul 2016 - Dec 2018
      • Associate Director - Global Program Management Immunology

        Dec 2017 - Dec 2018
      • Global Program Manager - Global Program Management Immunology

        Jul 2016 - Nov 2017
    • Takeda

      Jan 2019 - now
      • Director - Global Program Management (Plasma-Derived Therapies Business Unit)

        Jul 2020 - now
      • Associate Director - Global Program Management (Plasma-Derived Therapies Business Unit)

        Jan 2019 - Jul 2020
  • Licenses & Certifications

    • Project Management Professional (PMP)

      Project Management Institute
      Aug 2016
  • Honors & Awards

    • Awarded to Katharina Gschwandtner
      Plasma-Derived Therapies Business Unit (BU) Spotlight Award Plasma-Derived Therapies Business Unit (BU) President Mar 2022 Spotlight Award: This award recognizes individuals whose contributions and collaborations stands out across functions.
    • Awarded to Katharina Gschwandtner
      Project Management Excellence Award: Project Manager of the year (2014) Baxter Innovations Inc. Dec 2014