Lorène BERNASCONI

En résumé

Entreprises

• EmaCo - Head of Analytical and Bioanalytical Development

  2019 - maintenant Responsibilities:
  • Resource planning, project timelines and budget
  • Staff management
  • Functional leader
  • Responsible for analytical and bioanalytical method development / qualification / validation / transfer
  • Responsible for early forced degradation, formulation and stability assessment studies
  • Responsible for product characterization and CQA assessment
  • Responsible for process characterization studies to support DS and DP process validation
  • Responsible for technical oversight of external CMO/CROs for analytical and bioanalytical activities (method transfer / validation, product characterization).
  • Responsible for Analytical Service activities
  • Responsible for maintaining and optimizing quality system within the team
  • Responsible for GDocP internal documentation
  • Writing/reviewing of CMC sections of IND/IMPD, BLA/MAA
  • Technology watch
  
  Technical skills:
  • Potency and immunochemical assays (ELISA, flow cytometry)

• Novimmune - Analytical Development Lab Manager to support high concentration and bispecific mAb characterization

  2017 - 2019 Responsibilities:
  • Prioritization, resources, timelines and team management
  • Development and qualification of analytical methods adapted to low and high concentration and bispecific products
  • Design of formulation, forced degradation
  • CQA assessment and process characterization studies to support DS and DP process validation
  • Technical oversight of external CMO/CROs for analytical activities (method transfer/validation, product characterization)
  • Technical oversight of long-term product stabilities (quality and shelf life) and giving set compatibility studies
  • GDocP documentation writing and reviewing
  • Internal and external presentation of the results
  • Writing/reviewing of CMC sections of BLA/MAA
  • Technical support for BLA/MAA submission and reviewing process
  • Technology watch
  
  Technical skills:
  • Spectrophotometry UV-Vis, Liquid particles counting (high concentration product), Container closure integrity
  • Capillary electrophoresis: CE-SDS (purity assessment)
  • UPLC UV/FLR/QDa (characterization)

• NovImmune - Analytical Development Lab Manager to support process validation

  2014 - 2016 Responsibilities:
  • Timelines management
  • Technician and assistant management
  • Literature research
  • Suppliers contact
  • Development and qualification of high throughput analytical methods
  • Report and SOP writing
  
  Technical skills:
  • Capillary electrophoresis: CE-SDS, ic-IEF (purity and identity assessment)
  • UPLC (characterization)
  • ELISA (impurity quantitation)
  • qPCR (impurity quantitation)

• NovImmune - Formulation, Development and Analytical Support Assistant

  2013 - 2013 Responsibilities:
  • Design and realization of formulation, forced degradation and stability studies
  • Literature research
  • Development and qualification of analytical methods
  • Troubleshooting investigation and solving
  • Report and OM writing
  • Internal presentation of the results
  
  Technical skills:
  • Gel electrophoresis: SDS-PAGE, IEF
  • HPLC : SEC, IEX, HIC, Affinity (Protein A, Boronate), RP
  • ELISA 
  • Spectrophotometry UV-Vis
  • Liquid particles counting
  • Visual control (colour, particles)
  

• NovImmune - Analytical support assistant

  2012 - 2012 Responsibilities:
  • In-process and final sample quality control testing for manufacturing and research departments
  • Data treatment, interpretation and results delivery
  • Results discussion with the team
  • Work in accordance with the GLP
  • Laboratory organisation
  • First maintenance and calibration of equipments
  • Consumable stocks management
  • Suppliers contact
  
  Technical skills:
  • Gel electrophoresis: SDS-PAGE, IEF
  • HPLC : SEC, IEX, HIC
  • ELISA : kits
  • Spectrophotometry UV-Vis

• BioMérieux SA - Stage ingénieur industrialisation

  MARCY-L'ETOILE 2011 - 2011 Optimisation d'un procédé de purification sur protéine A d'anticorps
  
  Réalisations:
  • Etude technique des méthodes de purification en cours d'utilisation dans l'unité DSP
  • Recherche d'amélioration du procédé (automatisation), de diminution des coûts
  • Evaluation de nouvelles solutions technologiques (cellules à concentrer, fibre creuse)
  • Travail dans un contexte de qualité (ISO 9001)
  • Management de projet en utilisant la méthode de Kepner et Tregoe
  • Rédaction de protocoles et de rapports
  

Formations

• Institut National Des Sciences Appliquées

  Lyon 2008 - 2011 Formation scientifique et technique dans les sciences de la vie et de la santé, de l’environnement et de l’agro-alimentaire, du management, de contrôle, de la qualité et du conseil aux entreprises, mais aussi dans divers domaines de la chimie.

• INSA De Lyon

  Lyon 2006 - 2011

• Institut National Des Sciences Appliquées

  Lyon 2006 - 2008 Classe préparatoire à la formation d'ingénieur : enseignements scientifiques fondamentaux et sciences humaines (langues, communication, management).
  Classe réalisée au sein d'un groupe d'étudiants d'Amérique Latine.

• Lycée Docteur Lacroix

  Narbonne 2003 - 2006 Option Sciences et Vie de la Terre
  Spécialité Physique/Chimie

• Lycée Docteur Lacroix

  Narbonne 2003 - 2006 Option SVT- Spécialité Physique/Chimie

Réseau

• Baptiste VIGNASSE

• Cécile BATIER

• Denis BOUILLET

• Direction TECHNIQUE

• Hélène CHEVALLIER

• Marc GOMEZ

• Marion BACCINO

• Pierre-Jean COUBLE

• Romain GASSIAT

• Veronique BRUSA