Menu

Sylvain RAIMONDI

DOUVAINE

En résumé

Currently Leading the analytics unit in the Bioprocess R&D department at Novimmune SA (Geneva, Switzerland) focusing on developing therapeutic monoclonal and bispecific antibodies for inflammatory diseases and immune-related disorders. Drug substance and drug product stability studies, preformulation studies, investigation studies, analytical development and method qualification/validation, Process Characterization Studies for DS and DP Process Validation. Responsible for the management of outsourced CMC activities with CRO/CMOs including drug substance storage, drug product manufacture and assay transfer/validation.
Prior to joining Novimmune in 2005, immunology department at Covance, a Swiss-based CRO. From 2001 to 2005, Research associate in charge on the chemical synthesis of peptides and small proteins used in in vitro models in the synthesis department at GeneProt (Switzerland), a startup company working on the proteomic domain. Prior to GeneProt, Research assistant at Virbac (France), a company specialised in animal health, on therapeutic and vaccine approaches in the research and development department. Masters degree in molecular chemistry from the University of Grenoble (France).

Mes compétences :
HPLC
Western Blotting
Antibody
term Product development
UPLC
Staff supervision
R&D
Quality Assurance
Protocols
Project Management Training
Microsoft Windows
Lead Candidate Selection
LC-MS
Immunology
Immunoassay
GC-MS
ELISA
Drug Delivery
DNA extraction
Calibration
Business Process Improvement
Analytical process development
Analytical method development

Entreprises

  • Novimmune - Head, Analytics Unit - Bioprocess R&D

    2011 - maintenant Main Responsibilities:
    Analytical process development/validation for therapeutic monoclonal and bispecific antibodies
    CQA assessment and Process Characterization Studies to support DS and DP Process Validation
    DP manufacture and DS/DP stability and storage
    Long-term Product development (quality and shelf life)
    Analytical method development and validation
    Forced degradation studies, high concentration solubility studies, re-formulation, toxicological material, giving set compatibility studies
    Technical oversight of external CMO/CROs for analytical activities (method transfer/validation, release testing, GMP stability studies)
    Strategy/prioritization/resource/timeline/budget for a team of 8 people

    Analytical expertise: IEX-HPLC, HIC-HPLC, Protein A/G-HPLC, Peptide mapping, RP-HPLC/UPLC, MCS-LAL system, Analytical particle counting system, Wyatt system (Light Scatering Detector, Refractometer, Field-Flow-Fractionation), icIEF, CE-SDS, HCP ELISA, DNA qPCR, ProtA ELISA, Peroxide quantification (PEROXsay kit), dye staining, DSF

  • Novimmune - Head, Formulation Development Unit - Manufacturing

    2009 - 2011 Management of formulation projects: Lead Candidate Selection, stability studies, forced degradation studies, high concentration solubility studies, re-formulation, evaluation and implementation of new analytical techniques and methods
    Development of analytical methods: IEX-HPLC, Protein A/G-HPLC, Peptide mapping and RP-HPLC, Peroxide quantification (PEROXsay kit), dye staining
    Implementation of MCS-LAL system, analytical particle counting system, Wyatt system (Light Scatering Detector, Refractometer, Field-Flow-Fractionation)
    Maintenance of the QA system

  • Novimmune - QC/Analytics Laboratory Manager - Manufacturing

    2007 - 2009 Management of analytical projects: Lead Candidate Selection, pre-formulation, DRF material, Drug Product and Drug Substance stability studies, giving set studies, analytical method development and validation
     Analysis and characterization of monoclonal antibodies by: SEC-HPLC, Particle counting system, SDS PAGE and IEF electrophoresis, densitometry, spectrophotometric methods (UV, fluorescence)
     Equipment qualification and calibration
     Reviewing and adaptation of SOPs for the QC/analytical laboratory
     Training for QC/analytical laboratory staff
     Staff supervision

  • Covance CLS - Medical Technologist, Immunology laboratory

    2005 - 2007 Laboratory tests under GCP conditions according to quality assurance and control procedures
    Chemiluminescence immunoassay and fluoroimmunometric assay
    Enzyme immunoassays
    Immunodetection by Western Blot

  • Geneprot - Research Associate, Peptide synthesis laboratory

    2001 - 2005 Research and production projects involving peptides and proteins for biological tests under GLP conditions ; involved in various research and development projects to improve productivity
    Organic synthesis of precursors and preparation of modified amino acids and resins
    Chemical synthesis of peptides and proteins (Boc and Fmoc chemistry)
    Use of cleavage techniques with fluorhydric acid
    Native chemical ligation
    Proteins folding
    Characterization and analysis of proteins by LC-MS/MS and purification by HPLC
    Responsiblility for the maintenance and the calibration of the mass spectrometers
    Writing of standard operational procedures

  • Virbac - Research Assistant, Research and Development laboratory

    Carros 1999 - 2000 Studies on therapeutic and vaccine approaches of F.I.V. (Feline Immuodeficiency Virus) and Fe.L.V. (Feline Leucosis Virus) ; stability studies on bulk and finished products
     Production of recombinant proteins
     Analysis and purification of proteins (FPLC, HPLC, electrophoresis, densitometry)
     Immunodetection by Western Blot and Dot Blot
     Serological follow-up by ELISA

  • CEA-Grenoble (France) - Internship, Nucleic acids lesions laboratory

    PARIS 1997 - 1998 Nucleic acids lesions laboratory
    Measurement of oxidized bases in cellular DNA using 32P post-labelling method
     Chemical and photochemical synthesis of modified bases
     32P post-labelling method
     DNA extraction methods
     Use of chromatographic (CCM, HPLC, GC-MS) and spectroscopic (UV, IR) methods

Formations

  • Joseph Fourier University Grenoble 1

    Grenoble 1997 - 1998 Masters Degree in Molecular Chemistry

    Honours 2.1

  • Joseph Fourier University Grenoble 1

    Grenoble 1995 - 1997 Bachelor Honours Degree in Biochemistry

  • University Of Savoie (France) (Chambery)

    Chambery 1993 - 1995 Diploma in Science of Nature and Life

  • Lycée La Versoie (Thonon Les Bains)

    Thonon Les Bains 1992 - 1993 Baccalaureate in Mathematics and Science of Nature

Réseau

Annuaire des membres :