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Ralf D. Hess, MSc, PhD

Ralf D. Hess, MSc, PhD

Post-Doc

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  • Timeline

  • About me

    ENTOURAGE GmbH, Principal Project Consultant, Member of Entourage Task Force,Resource & Expertise in Life Sciences

  • Education

    • Universität Freiburg

      1982 - 1991
      Diplom und Dr. rer. nat. Biologie: Virologie/Immunologie 1,4 und Magna cum laude

      Activities and Societies: ESCV since 2004; GfV since 1990 ; DGHM (Deutsche Gesellschaft für Mikrobiologie und Hygiene) since 1999; BioValley Deutschland e.V. (Freiburg, Germany) since 1996; Member of European QP (Qualified Person) Association since 2007; European Society of Virology (new organization (04/09), member since June 2009; PDA (Parenteral Drug Association) from 2014 (committee member PDA mabs workshop), ECA (European Compliance Academy) from 2014.

  • Experience

    • Universität Freiburg, Department of Virology

      Jul 1991 - May 1996
      Post-Doc

      • Peptide-based vaccines, adjuvants and Biological Response Modifyers (BRM), 1991 – 1993.• Experimental oncology, cell cycle and p53-dependent apoptosis and signal transduction of tumor suppressor protein p53, 1993 - 1996.• Medical Virology and Epidemiology 1987 - 1996• Part time lecturer, holding courses and holding examinations in “Medical Microbiology” (1988-1996).• Responsible for signing off virologic reports, day and weekend services as “physician”/virologist on duty 1995 – 1996. Show less

    • HISS Diagnostics GmbH

      Jun 1996 - Jun 2007
      Chief Scientific Officer

      Product Management, Manufacturing, Regulatory Affairs, CE-Marking, ISO 13485 Compliance Manager for In-Vitro Diagnostic Medical Devices, Business Development, world wide

    • PAREXEL

      Jul 2007 - Dec 2015
      Principal Consultant

      >8 years track record of biologics (mabs) CMC, quality assurance, PD assay development and validation (ADA, MoA), regulatory affairs and GxP (GMP, GLP, GCLP) – drug substance, drug product and quality laboratory auditing, GMP, (Eudralex Volume 4) GLP (EU Directives & US 21 CFR part 58) and GCLP (EMA reflection paper) implementation, 5 years qualified person (Swiss Medic), medical device development (design control, 21 CFR part 820.30) and ISO 13485 audits, visiting lecturer for regulatory affairs for biologics (5 years), drug-device combination products regulatory pathway for authorization/approval (EU Directives and 21 CFR part 820 and part 4), biomarker development until approval (EU and US); Show less

    • Inresa Arzneimittel GmbH

      Jan 2016 - Mar 2017
      Scientific Director

    • TPL Path Labs

      Apr 2017 - Jan 2018
      Chief Strategy and Compliance Officer

    • AVA LIFESCIENCE GmbH

      Feb 2018 - Apr 2019
      HEAD QA & REGULATORY AFFAIRS

      IVD Medical Devices, CDx, Drug Development, ISO 13485:2016; ISO 14971, CMC/Quality/Regulatory Affairs

    • Entourage

      May 2019 - now
      Principal Project Consultant

  • Licenses & Certifications

    • QMS Auditor/Lead Auditor based on ISO 13485:2012 Training Course

      Kelmac Group
      Jan 2015

    • APIC certified Auditor

      APIC ICHQ7 Biologics
      Jun 2014