Highlights:Become a member of Harvard Medical School Regular participation in European Medicines Agency meetings

Skills:Immunology, Regulatory Affairs, Chemistry Manufacture Controls

Goal:Get a position related to Regulatory Affairs - CMC in US pharma companies

Membership:Spanish Immunology Society

Certification:Spanish Board Certificate in Immunology

CMC Quality Assessor 06/2021 - current
Spanish Agency of Medicines and Medical Devices, Madrid, Madrid Spain
Industry: Regulatory
Quality evaluation of Investigational Medicinal Product Dossiers for Clinical Trials authorization. Scientific advices for pharma industries. Chemistry, Manufacturing and Control (CMC). Division of Biological Products, Advanced Therapies and Biotechnology. European Medicines Agency expert.
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CMC Scientific Advisor 01/2020 - 05/2021
Spanish Agency of Medicines and Medical Devices, Madrid, Madrid Spain
Industry: Regulatory Affairs
Quality evaluation of Investigational Medicinal Product Dossiers for Clinical Trials authorization. Scientific advices for pharma industries. Chemistry, Manufacturing and Control (CMC). Division of Biological Products, Advanced Therapies and Biotechnology. European Medicines Agency expert.
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Research Fellow 08/2016 - 07/2019
Massachussets General Hospital, Boston, MASSACHUSETTS United States
Industry: Academical Research
Research on Lyme arthritis (LA). Phenotypic and functional characterization of lymphocytes, monocytes and dendritic cells in synovial fluid and synovial tissue from antibiotic-responsive and post-infectious LA patients.
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Postdoctoral Fellow 01/2014 - 05/2016
Medizinische Hochshule Hannover, Hannover, Lower Saxony Germany
Industry: Academical Research
Analysis of surface expression of Leukocyte Immunoglobulin-like Receptors on peripheral blood mononuclear cells from rheumatoid arthritis and spondyloarthropaties patients. Determination and distribution of Leukocyte Immunoglobulin-like Receptor member A3 (LILRA3) non-functional variants by multiplex PCR in autoimmune diseases. Production of LILRA3-Fc fusion proteins.
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Head Associate Immunology 03/2012 - 06/2012
Hospital Puerta de Hierro Majadahonda, Madrid, Madrid Spain
HLA-Immunogenetics clinical determinations
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Postdoctoral Researcher 09/2012 - 11/2013
Hospital Puerta de Hierro Majadahonda, Madrid, Madrid Spain
Industry: Academical Research
Research on Killer-cell Immunoglobulin-like Receptors (KIR) and Leukocyte Immunoglobulin-like Receptor member A3 (LILRA3) genetic variability.
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Predoctoral Researcher 07/2009 - 02/2012
Hospital Puerta de Hierro Majadahonda, Madrid, Madrid Spain
Research on Killer-cell Immunoglobulin-like Receptors (KIR) and Leukocyte Immunoglobulin-like Receptor member A3 (LILRA3) genetic variability.
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Immunology Resident 05/2005 - 05/2009
Hospital Puerta de Hierro Majadahonda, Madrid, Madrid Spain
Clinical determinations in Immunology, including Immunochemistry, Autoimmunity, specific IgE determinations, Lymphocyte populations and HLA-Immunogenetics. Emergency Histocompatibility determination for renal transplants.
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Universidad de Oviedo 10/1997 - 06/2002
Oviedo, Asturias, Spain
Degree: Bachelor's Degree
Major:Pass
Bachelor in Science. Biology/Biotechnology

David Ordóñez del Valle 2022 2022