Rungis
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.
Mes compétences :
Screening
Validation
Pas de formation renseignée
