Dr. Sven Hagen

Angestellt, Director CMC Validation and Compliance, T-knife GmbH
Berlin, Germany

Fähigkeiten und Kenntnisse

ATMP regulatory environment
project management
Process Validation
consumer health care
Viral Gene Therapy
pharmaceutical process validation
GMP Manufacturing of human cells

Werdegang

Berufserfahrung von Sven Hagen

  • Current 4 years and 5 months, since Jan 2022

    Director CMC Validation and Compliance

    T-knife GmbH
  • 2 years and 10 months, Mar 2019 - Dec 2021

    Head of Production Excellence / Contract Manufacturing

    co.don AG

  • 2 years and 11 months, May 2016 - Mar 2019

    QA / RA ATMP Process Validation & Scientific Writer for EMA/EU approval

    co.don AG

    1. Project Management for clinical studies 2. Negotiations and communication with respective European authorities & external partners

  • 8 years and 1 month, Jun 2010 - Jun 2018

    board member

    iGEM e.V. Deutschland

  • 5 months, Jan 2016 - May 2016

    Independent scientist

    University of Potsdam, Molecular Biotechnology

    enhancement of a self-developed rapid, strain-specific diagnostic test for Borrelia, negotiations regarding the patenting process with the University of Potsdam

  • 3 months, Jul 2015 - Sep 2015

    Interim Head of Laboratory

    Medizinisches Infektiologiezentrum Berlin

    Interim Head of a specialty diagnostics lab with focus on HIV / HCV / HBV part. management responsibility for 5 med. tech. assistants, set up of a specialist laboratory (focus on HIV, HCV, HBV diagnostics) with responsibility for construction planning, equipment requirements / negotiations and IT infrastructure

  • 2 years, Jan 2009 - Dec 2010

    Project Management

    Albert-Ludwigs-Universität Freiburg

    Project management with shared management responsibility (iGEM team instructor) for up to 15 coworkers, Project volume 45.000 € University of Freiburg, Research Excellence Cluster BIOSS within the framework of the “international Genetically Engineered Machine competition (iGEM)”, MIT, Cambridge, USA; Scored among the 6 best projects worldwide (120 projects in total); Awards: Best Health/Medicine Project (2010), Best Engineered Biological Part (2009), Best Poster (2009), Gold Medal (2009/2010)

  • 4 months, May 2010 - Aug 2010

    Project Supervisor - RISE program DAAD

    German Academic Exchange Service (DAAD)

    Project supervisor within the framework of the “Research Internships in Science and Engineering” (RISE) program, German Academic Exchange Service (DAAD)

  • 3 years and 8 months, May 2005 - Dec 2008

    Research Assistant

    Universitätsmedizin Göttingen
  • 4 months, Jul 2004 - Oct 2004

    Research Assistant

    KWS SAAT AG

  • 3 months, Jun 2002 - Aug 2002

    Research Assistant

    Sartorius

Ausbildung von Sven Hagen

  • 2013 - 2015

    Consumer Health Care

    Charité – Universitätsmedizin Berlin

    legal basis of consumer healthcare; clinical pharmacology, biostatistics and self medication; pharmacoepidemiology & -economy; quality assurance and health management; methodological principles & basic knowledge in pharmacovigilance; methodology of clinical and pharmacoepidemiological studies

  • 3 years and 9 months, Apr 2011 - Dec 2014

    Molecular & Synthetic Biotechnology

    Universität Potsdam - Institute of Biochemistry & Biology

    cancer research, tumor biology, synthetic biology “Characterization and inhibition of AF10-mediated interaction in acute myeloid leukemia using a synthetic inhibitory peptide and development of a modular viral-vector-based targeting system”

  • 5 years and 1 month, Mar 2002 - Mar 2007

    Biology

    Georg-August-Universität Göttingen

    Pharmocology, Toxicology, Neurodegenerative Disorders

Sprachen

  • English

    C1 (Fließend)

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

XING – Das Jobs-Netzwerk

  • Über eine Million Jobs

    Entdecke mit XING genau den Job, der wirklich zu Dir passt.

  • Persönliche Job-Angebote

    Lass Dich finden von Arbeitgebern und über 20.000 Recruiter·innen.

  • 21 Mio. Mitglieder

    Knüpf neue Kontakte und erhalte Impulse für ein besseres Job-Leben.

  • Kostenlos profitieren

    Schon als Basis-Mitglied kannst Du Deine Job-Suche deutlich optimieren.

21 Mio. XING Mitglieder, von A bis Z