Dr. Kerstin Rumpelmayr

Angestellt, Senior Director Technical Development, Hookipa Biotech GmbH

Wien, Österreich

Fähigkeiten und Kenntnisse

Lifecycle Management
Risk Management
Quality by Design (QbD)
Process Development
Project management
GMP specialist
technology transfer
process validation specialist
experience in pharmaceutical industry (Biotechnolo
process knowledge (fermentation and purification o
Regulatory Filing
Audit
CMC
Pharmaceutical Development
GMP

Werdegang

Berufserfahrung von Kerstin Rumpelmayr

  • Bis heute 1 Jahr und 7 Monate, seit Nov. 2022

    Senior Director Technical Development

    Hookipa Biotech GmbH

  • 1 Jahr und 11 Monate, Jan. 2021 - Nov. 2022

    Head of Process Science, Principal Scientist

    Themis Bioscience, a subsidiary of Merck & Co.

    Leading a team of scientists and Project Managers for Bioprocessing (Drug Substance & Drug Product) and Analytical Development as well as cross-functional project teams; Product life cycle strategist and technical expert for biological products (e.g., vaccinces, recombinant proteins, mAbs, CAR-T cells) overseeing all aspects of CMC development like process development, GMP manufacturing and testing as well as Regulatory CMC tasks (IMPDs, INDs, scientific advices etc).

  • 1 Jahr und 9 Monate, Apr. 2019 - Dez. 2020

    CMC Lead

    Themis Bioscience, a subsidiary of Merck & Co.

    Leading a team of scientists for Upstream and Downstream Bioprocess and Analytical Development as well as cross functional project teams working in biopharmaceutical product development; product life cycle strategist and technical expert for vaccines overseeing activities related to process development, manufacturing and interactions with regulatory authorities.

  • 3 Monate, Jan. 2019 - März 2019

    CMC Lead, Associate Director

    Takeda

    Technical Operations Team Lead for development products

  • 2 Jahre und 4 Monate, Okt. 2016 - Jan. 2019

    CMC Lead, Associate Director - Process Development & Technical Services

    Shire

    Technical Operations Team Lead for development products

  • 5 Monate, Juni 2016 - Okt. 2016

    Sr. New Product Owner, Manager

    Shire

    Process and Product Expert for Development Products (Biosimilars and Biotherapeutics)

  • 1 Jahr und 6 Monate, Jan. 2015 - Juni 2016

    Sr. New Product Owner, Manager

    Baxalta Innovations GmbH

    Process and Product Expert for Development Products

  • 1 Jahr und 8 Monate, Juni 2013 - Jan. 2015

    Manufacturing Engineer - Extractables&Leachables Expert

    Baxter BioScience

  • 2 Jahre und 2 Monate, Apr. 2011 - Mai 2013

    Quality/ Validation Specialist

    Baxter Bioscience

    Process Quality Assurance, GMP Specialist

  • 4 Jahre und 9 Monate, Aug. 2006 - Apr. 2011

    Research Scientist/ PhD candidate

    Universität Wien

Ausbildung von Kerstin Rumpelmayr

  • 6 Jahre und 4 Monate, Aug. 2006 - Nov. 2012

    Chemie

    Universität Wien

    Massenspektrometrie

  • 5 Jahre und 9 Monate, Okt. 2000 - Juni 2006

    Chemie

    Universität Wien

    Analytische Chemie, Archäometrie, Lebensmittelchemie, Biochemie

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

  • Französisch

    Fließend

Interessen

Archäologie
Archäometrie
Ägyptologie
Anthropologie
Chemie
Kultur
Kochen
Yoga

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