Dr. Ralf Hess

Angestellt, Principal Project Consultant, Entourage GmbH

München, Deutschland

Fähigkeiten und Kenntnisse

Dr. Ralf D Hess
The Entourage Task Force
certified APIC(ICHQ7) auditor
certified IRCA ISO 13485 Lead auditor
Principal Consultant
at PAREXEL Consulting
in vitro diagnostic medical device and drug develo
recombinant proteins
draws on + 30 years R&D
GxP compliance
vaccines
peptide-based vaccines
and cellular and biologic therapies (ATMP) targeti
infectious diseases
and autoimmune diseases. Dr. Hess utilizes his ex
EMA
helping with developing assays for PK and PD
biologics drug release testing (ligand-binding and
companion diagnostics and quality systems implemen
ISO 15189
Basel
Switzerland. Prior to joining PAREXEL
Dr. Hess has held a position in industry as CSO (C
Freiburg
Germany. Dr. Ralf D Hess holds a PhD in virology/
and MSc degree biology from University of Freiburg
and has completed postdoctoral studies in virologi
cellular immunology and in vitro oncology at the D
such as DIA and others and has authored several ar
he is also a course leader and lectures at EUCRAF
drugs and devices.
Registerd as 2nd QP with Swiss Medic 2007-2012

Werdegang

Berufserfahrung von Ralf Hess

  • Bis heute 5 Jahre, seit Mai 2019

    Principal Project Consultant

    Entourage GmbH
  • 1 Jahr und 3 Monate, Feb. 2018 - Apr. 2019

    Head QA & Regulatory Affairs

    AVA Lifescience. GmbH

  • 10 Monate, Apr. 2017 - Jan. 2018

    Chief Strategy and Compliance Officer

    TPL Path Labs
  • 1 Jahr und 3 Monate, Jan. 2016 - März 2017

    Scientific Director

    Inresa Arzneimittel GmbH

    Scientif Director, Head Quality Assurance, Head Manufacturing

  • 8 Jahre und 6 Monate, Juli 2007 - Dez. 2015

    Principal Consultant

    PAREXEL International

    Consulting for: cGMP FDA/EU compliance EU GMP Guide 21 CFR part 210/211 21 CFR part 820 GLP ISO 13485/ISO 17025/ ISO 15189 auditor Early stage drug and medical devices development QP with SWISS Medic Auditor Drug Substance/Drug Product Manufacturer

Ausbildung von Ralf Hess

  • Diplom Biologe

    Universität Freiburg

    Virologie/Tumorvirologie/Medizinische Virologie

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

  • Französisch

    Grundlagen

  • Italienisch

    Grundlagen

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