Stephane CHIRON

Senior CMC manager at Affimed
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Contact Information
us****@****om
(386) 825-5501
Location
Lyon, Auvergne-Rhône-Alpes, France, FR
Languages
  • francais Native or bilingual proficiency
  • Anglais Native or bilingual proficiency

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Experience

    • Germany
    • Biotechnology Research
    • 100 - 200 Employee
    • Senior CMC manager
      • Apr 2023 - Present

    • France
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Project Management Consultant
      • Feb 2022 - Mar 2023

      Global Regulatory Affairs Project Manager on COVID vaccine Global Regulatory Affairs Project Manager on COVID vaccine

    • France
    • Business Consulting and Services
    • 100 - 200 Employee
    • Project Management Consultant
      • Feb 2022 - Mar 2023

    • France
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Project Manager CMC
      • Apr 2019 - Jan 2022

      CMC: Chemistry, Manufacturing and Controls Specialized in Biologics. Project management Collaboration with partners (CDMOs, CMOs and CROs) Analytical Sciences (Characterization and method Validation) CMC documentations (CTD/ICH module 3, URS, ...) Regulatory Compliance (GxPs, ICH, ...) » Project management with Clinical Department and Chief Operating Officer. » CMOs and CROs management. » Biological Drug Substances/Drug Products Characterizations. » Supply Management, Starting materials and consumables with CMOs. » Drug Substance and Drug Product production management. » Preparation of Process Validation as per GMP and ICH guidelines. » Development of New Analytical Methods. » Management of Method Validation by CRO as per ICH guidelines. » Management of Stability studies; planning, follow-up and reviews. » Regulatory documents management; Scientific Advices, URS, IMPD. Show less

    • Switzerland
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Project Manager CMC
      • Apr 2019 - Jun 2021

      CMC: Chemistry, Manufacturing and Controls Specialized in Biologics. CMC: Chemistry, Manufacturing and Controls Specialized in Biologics.

    • France
    • Higher Education
    • 100 - 200 Employee
    • Project Leader / Research Scientist
      • Apr 2016 - Jan 2019

      Multiomics. High throughput microfluidics in Biology. Projects development; implication in a Proof of Concept grant from ERC and a funding from Bpifrance (PSPC) in collaboration with HiFiBiO. Projects management and co-management of researchers, postdocs and PhDs. Development of a process “femtoliter scale microfluidics” for in-vitro protein evolution, using in-vitro compartimentalized self-replication. Application of microfluidics to perform ELISA into nanoliter droplets, for secretion analysis. Development of CITE-Seq in conjunction to scRNA-Seq for immunity/cancer cell interactions. Development of new technologies and approaches for single cell analysis using NGS as readout. Analysis of Illumina sequencing (Big Data Analysis using R and Python). Show less

    • France
    • Biotechnology
    • 1 - 100 Employee
    • Project leader R&D
      • Sep 2013 - Jun 2014

      Production of C3P3®; a high yield In Vitro Transcription systems for mRNA production. Project management, under supervision of the scientific director. Creation and structuration of the laboratory. Creation and Development of a new process to quantify the capping efficiency of RNAs. Production of C3P3®; a high yield In Vitro Transcription systems for mRNA production. Project management, under supervision of the scientific director. Creation and structuration of the laboratory. Creation and Development of a new process to quantify the capping efficiency of RNAs.

    • France
    • Research Services
    • 700 & Above Employee
    • Post-doctoral Researcher
      • Mar 2012 - Mar 2013

      Ionizing radiations on muscle and cell therapies approaches. Radio-pathology and Experimental Therapy Laboratory (LRTE). R. Tamarat Project management and management of a research engineer. Identification of a long term muscular hypotrophy after irradiation. Characterization of muscle stem cell morbidity in vivo after irradiation. Small animal (mice) experiments Irradiation experiments FACS analysis and cell sorting Muscle stem cells isolation and culture Ionizing radiations on muscle and cell therapies approaches. Radio-pathology and Experimental Therapy Laboratory (LRTE). R. Tamarat Project management and management of a research engineer. Identification of a long term muscular hypotrophy after irradiation. Characterization of muscle stem cell morbidity in vivo after irradiation. Small animal (mice) experiments Irradiation experiments FACS analysis and cell sorting Muscle stem cells isolation and culture

    • Post-doctoral Researcher
      • Mar 2010 - Dec 2011

      Set up and uses of 3D cell culture system for studies on myogenesis and mechanotransduction. Therapies of the disorders of striated muscle. C. Coirault Project and team management, composed of two research engineers and a student. Creation of 3D culture of primary muscular human cells. Characterization of the differences in cellular adhesions between 3D and 2D cultures. Primary muscle cell culture Tridimensional (3D) culture Confocal microscopy (Scanning) Set up and uses of 3D cell culture system for studies on myogenesis and mechanotransduction. Therapies of the disorders of striated muscle. C. Coirault Project and team management, composed of two research engineers and a student. Creation of 3D culture of primary muscular human cells. Characterization of the differences in cellular adhesions between 3D and 2D cultures. Primary muscle cell culture Tridimensional (3D) culture Confocal microscopy (Scanning)

    • United States
    • Higher Education
    • 700 & Above Employee
    • Post-Doctoral Researcher
      • Jul 2008 - Dec 2009

      Transcriptional regulation of chromogranin A in neuroblastoma and pheochromocytoma cells.Chromaffin Cell and Hypertension Research Laboratory. D.T. O'ConnorProject development and management - co-management of two master students.Identification of the transcription factor modulating CHGA expression in hypertension.Human geneticsSNPsMammalian cell culturesBiochemistry

    • Post-doctoral Fellow
      • May 2005 - Jun 2008

      Study of the interactions of mitochondria with the microtubule cytoskeleton, in S. pombe.Mitochondrial Inheritance and Morphology Laboratory. M.P. YaffeProject creation and management, with a support from the United Mitochondrial Disease Foundation (98,500$) – management of master and PhD students.Characterization of CLASP, a protein binding mitochondria to microtubules.Yeast geneticsCell biologyConfocal microscopy (Spinning disk)Live cell time lapse imagingMolecular biology Show less

    • France
    • Research Services
    • 700 & Above Employee
    • Doctorant
      • Sep 2001 - Mar 2005

      Doctorat es Sciences Study of mitochondrial translation in the yeast Schizosaccharomyces pombe. At Centre de Génétique Moléculaire, Gif-sur-Yvette, 91 Biogenesis and function of mitochondrial respiratory complexes Laboratory. Characterization of the functional conservation between human and S. pombe factors. Identification of drastic mtDNA depletion in S. pombe during translation blockade. Yeast genetics Mitochondrial genetic and biology Molecular biology Doctorat es Sciences Study of mitochondrial translation in the yeast Schizosaccharomyces pombe. At Centre de Génétique Moléculaire, Gif-sur-Yvette, 91 Biogenesis and function of mitochondrial respiratory complexes Laboratory. Characterization of the functional conservation between human and S. pombe factors. Identification of drastic mtDNA depletion in S. pombe during translation blockade. Yeast genetics Mitochondrial genetic and biology Molecular biology

Education

  • Université Paris-Sud
    Research Doctorate, Génétique
    2001 - 2005
  • Université Paris-Sud
    DEA, Génétique
    2000 - 2001
  • Université de Poitiers
    Maitrise, Biologie Cellulaire et Physiologie
    1999 - 2000
  • La Rochelle Université
    Licence, Biologie Générale et Physiologie
    1998 - 1999
  • La Rochelle Université
    DEUG, Sciences de la Vie
    1996 - 1998

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