Francois Bertelli

Francois Bertelli

Principal scientist, Abbott Laboratories

A l'écoute d'opportunités
 

En poste chez Abbott Laboratories

Précédents : Pfizer

 

    En résumé

    Management of upstream and downstream Process Characterisation and Validation of Antibody/Antigen (Mammalian Cell culture and Fermentation) for manufacturing using cGMP methods. Expert in protein characterisation methods. As part of the Technical Operations team for Rare Reagents production and purification, I evaluate and improve the processes for large-scale protein production such as Monoclonal antibodies (Hollow-fiber, perfusion, wavebags, spinners) and the purification processes (Chromatography, Ultrafiltration, Dialysis, TFF). Supporting the Process Validation projects, making sure that activities are compliant with QMS and external guidelines (FDA & EU). * Facilitate risk assessment/FMEA process. * Performs in process test as required, analyze validation data and generate conclusions based on test results. Report the validation results in an accurate and timely manner * Review and approve validation plans and reports and lab manufacturing equipment qualification (IQ/OQ/PQ). * Perform QMS maintenance activities and implement quality improvement activities. * Assures the accuracy and correctness of documentation used during process validation activities. * Provide GMP guidance. 14 years experience in Assay Development and High-Throughput-Screening Project Management. I have a track record in prosecution of drug discovery programmes from idea to candidate nomination, across broad disease, target and physiological systems. I have experience of both leading teams directly and indirectly through matrix-based disciplines Broad knowledge of most of the therapeutic areas for which several HTS campaigns have been run successfully. I have received the project management foundation certficate PRINCE2. Specialties: Pharmacology, Enzymology, Cell-based assays, kinase and Protein-Protein Interaction assays. Project Management Drug Discovery. Protein Charaterisation. Le site de recherche en Angleterre fermant je suis a la recherche d'autres opportunites dans la gestion de projet de recherche dans l'industrie pharma en France, Suisse ou Belgique.

Parcours

Compétences

 
  • Screening
  • Validation

Langues parlées

 

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