Dr. Martin Kaliwoda

Angestellt, Analytical Fellow (Global Quality), Takeda GmbH

Vienna, Österreich

Fähigkeiten und Kenntnisse

Analytical Biochemistry
Process Development
Leadership
Biochemical Comparability
Change Management
in vitro Characterization
Bioanalytik
Pharma
Solution Design
SharePoint
Due Diligence
Project Management
Pharma Experience
Interface Management
global Teamplayer
Organisationstalent
Biosimilars
Vaccines
global CMC Submission
Regulatory Filing
Business Intelligence
Biochemische Analytik
Authentizität
Empathie
Teamentwicklung
Verantwortungsbewusstsein
Erfahrung
Integrität
strategische Planung
innovative Lösungen
Durchsetzungsvermögen
Zielorientierung
Analytical Sourcing
Continuous Process Improvement
FDA
EMA
AGES
GMP
CTD
HPLC
Mass Spec

Werdegang

Berufserfahrung von Martin Kaliwoda

  • Bis heute 4 Jahre und 4 Monate, seit Feb. 2020

    Analytical Fellow (Global Quality)

    Takeda GmbH

  • 3 Jahre und 1 Monat, Jan. 2015 - Jan. 2018

    Associated Director Analytical Coordination (Global Process Development)

    Baxalta Innovations GmbH | Shire

    Identification of global analytical core competences | Sourcing strategy to identify and evaluate strategic global 3rd party contractors for international analytical projects | Successful international rollout of an analytical task management system | Global Analytical Product Owner | Review, Co-authoring of submission documents | Member of extended CMC teams | Budgeting global | Design of Business Excellence projects | Change management | Member of Due Diligence teams | Lean Management and Implementation

  • 6 Jahre und 4 Monate, Sep. 2008 - Dez. 2014

    Senior Manager Analytical Development

    Baxter Innovations GmbH

    Head of Analytical Development team (25FTE) | Firefighting for global production issues | Analytical Method Developments | Product submission, global CMC characterization | Member of Due Diligence teams | Outsourcing of nonclinical assays | Analytical Product Owner | Operational and Developmental leadership | Change, interface management | Strategic development and implementation | Optimization and efficacy projects, data management, SharePoint, LIMS | Budgeting, forecasting and budget monitoring

  • 7 Jahre und 1 Monat, Aug. 2001 - Aug. 2008

    Manager Analytical Services & IS Support

    Baxter BioScience

    Head of Analytical Services & IS Support (8FTE) | Analytical Method Development for in-depth protein characterization | Firefighting for global production issues | Review, Co-authoring and supporting of IND, BLA, IMPD, IB and CTD documents | Enhancement of MS (Mass spectrometry) and HPLC capabilities | Strategy development for the analytical team | Budgeting | Design, programming and implementation of an GDP compliant documentation system | Design, refurbishment and move into additional lab space

  • 1 Jahr und 5 Monate, März 2000 - Juli 2001

    Manager Biochemical Analysis

    Baxter BioScience

    Analytical Method Development for in-depth protein characterization | Operational and Developmental leadership | Creation of awareness about the importance of ‘state of the art’ analytical capabilities | Strategy development for the analytical team | Enhancement of technical and personal resources

  • 3 Jahre und 2 Monate, Jan. 1997 - Feb. 2000

    Scientist Biochemical Analysis

    Baxter Hyland Immuno

    Application of carbohydrate analysis platform methods to enhance the characterization of internal glycoproteins | Characterization for product submissions, report creation | Technical support | IT development within organization

  • 4 Jahre und 5 Monate, Aug. 1992 - Dez. 1996

    PhD student

    Immuno AG

    Development and implementation of an ultra-sensitive carbohydrate analysis platform for the characterization of glycoproteins | PhD thesis | IT team development

Ausbildung von Martin Kaliwoda

  • 8 Jahre und 6 Monate, Okt. 1985 - März 1994

    Technische Chemie

    Technische Universität Wien

    Biochemie und Lebensmittelchemie

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

  • Visual Basic

    -

Interessen

DSLR | Foto
Reisen
Weltkulturerbe
Computer | VBA
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