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Sophie DARTHENAY

Puteaux

En résumé

Mes compétences :
Qualité

Entreprises

  • Kelly Services - Consultant Professional Staffing Life Science - Kelly Scientific

    Puteaux 2013 - maintenant Human Resources for scientific profiles.
    Recruitment of permanent scientific people for pharmaceutical, clinical, biotechnologies companies in Western Switzerland.

    Speciality area :
    - Manufacturing, CQ and AQ specialization.

    Profiles recruited :
    - All levels of the life Science sector (Bachelor, Master, Engineer, PhD, MD degree, ect.....)

    Sectors in Western Switzerland:
    - Pharmaceutical industries, Biopharmaceutical, Biotechnology, CRO, Medical Device, Food industries, Chemistry...

    PERM & TEMP positions

    Management on all recruitment phases:
    • Candidate sourcing : Job boards and Proactive sourcing.
    • Selection of candidates: Screening, Personal interview,..

    Administrative activities:
    • Establishment of employment contract.
    • Support the candidates on administrative procedures and about her/his relocalisation in Switzerland.
  • NovImmune - Senior manufacturing assistant

    2009 - 2013 Antibodies purification Development. Generic process evaluation at lab scale including:
    • Samples preparation: Desalting, Concentration, Concentration/Diafiltration UFDF, filtration, final formulation
    • Chromatography matrix or membranes tests: affinity, cation exchanger, anion exchanger, hydrophobic interaction, mixed mode.
    • Chromatography systems use: ÄKTApurifier™, ÄKTAprime™ plus, ÄKTAexplorer™, ÄKTApilot™
    • Characterization of the in-process and final samples: Proteins’ concentrations, ELISA , SEC, SDS-PAGE, IEF, LAL test
    • Improvement of quality controls criteria

    Antibodies Manufacturing at Pilot scale including:
    • Buffers manufacture: implementation of a new equipment, associated QA documentation elaboration and recording
    • Purification in the respect of the process validated in development and in respect of the dead lines

    Project documentation: data recording in laboratory notebook, preparation and recap of results in tables, summary reports and reports writing

    QA documentation improvements: manufacturing book and buffers documents redaction, updating QA existing documents

    Organization of the laboratory: collaboration with suppliers to use new material, new techniques

    Presentation of results to subcontractor, of poster to scientific conference
    Internal presentation of results and scientific papers
    Management of a lab technician: encadrement planning
  • Pierre Fabre - Clinical development assistant

    Castres 2007 - 2009 Development of assays in chemistry, biochemistry and immunology on biological samples:
    • Selection of the method
    • Planning of the assays
    • Validation of the method
    • Performance of the assays
    Elaboration of models in pharmacology:
    • Establishment of protocols
    • Planning of the study according to the equipment and human resources
    • Analysis of results
    • Reports writing
    Prospecting and collaboration initiation with subcontractors to perform assays
  • Pierre Fabre - Research Assistant in Protein Purification

    Castres 2006 - 2007 Purification of antibodies, antibodies fragments, recombinant proteins:
    Sample preparation: dialysis, concentration/diafiltration (TFF Labscale Millipore)
    Purification of the product of interest using chromatography of affinity (Protein A, IMAC), anion exchange (CaptoQ) or size exclusion
    Characterization the final product by electrophoresis, Western Blot, size exclusion, proteins’ concentration
  • Entremont-Alliance - Quality Assistant

    Annecy 2006 - 2006 Preparation of the site to the IFS certification
    Optimization of the existing system: corrective actions more efficient, new targets for directions and process review
  • Institue of food chemistry - Technician in Protein purification

    2005 - 2005 Management of an experimental project
    Enzyme extraction and purification process elaboration
    Final product characterization: proteins’ concentration, enzymatic activity, SDS-PAGE and IEF

Formations

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