Dr. Sven Hagen

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

Berlin, Deutschland

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

  • Bis heute 2 Jahre und 5 Monate, seit Jan. 2022

    Director CMC Validation and Compliance

    T-knife GmbH
  • 2 Jahre und 10 Monate, März 2019 - Dez. 2021

    Head of Production Excellence / Contract Manufacturing

    co.don AG

  • 2 Jahre und 11 Monate, Mai 2016 - März 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 Jahre und 1 Monat, Juni 2010 - Juni 2018

    board member

    iGEM e.V. Deutschland

  • 5 Monate, Jan. 2016 - Mai 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 Monate, Juli 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 Jahre, Jan. 2009 - Dez. 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 Monate, Mai 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 Jahre und 8 Monate, Mai 2005 - Dez. 2008

    Research Assistant

    Universitätsmedizin Göttingen
  • 4 Monate, Juli 2004 - Okt. 2004

    Research Assistant

    KWS SAAT AG

  • 3 Monate, Juni 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 Jahre und 9 Monate, Apr. 2011 - Dez. 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 Jahre und 1 Monat, März 2002 - März 2007

    Biology

    Georg-August-Universität Göttingen

    Pharmocology, Toxicology, Neurodegenerative Disorders

Sprachen

  • Englisch

    Fließend

  • Deutsch

    Muttersprache

Interessen

cancer research & biology
sailing teacher
ice skating
ninjutsu
competetive (open water) sailing

21 Mio. XING Mitglieder, von A bis Z