
Katharina Gschwandtner
Research Associate

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

University of Applied Life Sciences, Krems, Austria
2011 - 2013Master of Science (MSc) Regulatory AffairsCore 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 - 2009Diplom Ingenieur (DI) Medical and Pharmaceutical BiotechnologyCore 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 2009Research AssociateResearch 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 2015Led/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 2015Project Management Analyst - Program and Portfolio Management Vaccines
Mar 2012 - Jan 2014Project Management Associate - Program and Portfolio Management Vaccines
Jul 2009 - Feb 2012

Baxalta
Sept 2015 - Jun 2016Global Program Manager - Global Program Management Immunology
Shire
Jul 2016 - Dec 2018Associate Director - Global Program Management Immunology
Dec 2017 - Dec 2018Global Program Manager - Global Program Management Immunology
Jul 2016 - Nov 2017

Takeda
Jan 2019 - nowDirector - Global Program Management (Plasma-Derived Therapies Business Unit)
Jul 2020 - nowAssociate Director - Global Program Management (Plasma-Derived Therapies Business Unit)
Jan 2019 - Jul 2020
Licenses & Certifications

Project Management Professional (PMP)
Project Management InstituteAug 2016
Honors & Awards
- Awarded to Katharina GschwandtnerPlasma-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 GschwandtnerProject Management Excellence Award: Project Manager of the year (2014) Baxter Innovations Inc. Dec 2014
Languages
- enEnglisch
- deDeutsch
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