Luca Simeone Email and Phone Number
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Luca Simeone is a Director - Head of Early CMC Development and In-Process Analytics Drug Substance at GSK. They possess expertise in hplc, cromatografia, caratterizzazione, uv vis, chimica and 29 more skills. They is proficient in Inglese.
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Director - Head Of Early Cmc Development And In-Process Analytics Drug SubstanceGskSiena, It -
Director - Head Of Early Development & In-Process Analytics Drug SubstanceGsk Aug 2024 - PresentSiena, Toscana, Italia -
Associate Director, Head Of In-Process Analytics - Microbial Drug SubstanceGsk Dec 2019 - Aug 2024 -
Senior Scientist - Analytical Development, Team ManagerGsk Mar 2015 - Dec 2019Siena, ItaliaAfter GSK acquisition of Novartis Vaccines unit, I joined in GSK Vaccines unit with the same previous position.Team manager of a group of 7 people in the Analytical Development department. In this role I have the responsibility and management of several complex analytical platforms, in particular: Multi Angle Light Scattering (SEC-MALS) coupled with HPLC or UPLC, Evaporative Light Scattering-UPLC, Fluorescence and Circular Dichroism spectroscopies, Differential Scanning Calorimetry… Show more After GSK acquisition of Novartis Vaccines unit, I joined in GSK Vaccines unit with the same previous position.Team manager of a group of 7 people in the Analytical Development department. In this role I have the responsibility and management of several complex analytical platforms, in particular: Multi Angle Light Scattering (SEC-MALS) coupled with HPLC or UPLC, Evaporative Light Scattering-UPLC, Fluorescence and Circular Dichroism spectroscopies, Differential Scanning Calorimetry (DSC), Capillary Electrophoresis, SDS-PAGE Electrophoresis and Western Blot technics, Dynamic Light Scattering (DLS).Major Accountabilities and Expertise:- Validation and transfer of analytical methods to commercial manufacturing operations (QC Lab) following the ICH, FDA and WHO guidance - Implementation of Quality by Design approach for analytical methods and vaccines development - Introduce novel technologies/methods for analytical development activities- People management- Laboratory Management- Laboratory Instrument System Owner: management of instrument qualification and maintenance according to GMP requirements- Physicochemical studies for comparability purposes or reference standard-characterization- Characterization of glycol-conjugates, proteins and Outer Membrane Vesicles- Use of the Sentry Quality Platform for Change Request and Deviation report management. Show less -
Scientist Ii - Analytical Development Team ManagerNovartis Vaccines Jan 2014 - Feb 2015Siena, ItaliaTeam manager of a group of 7 people in the Analytical Development department. In this role I have the responsibility and management of several complex analytical platforms, in particular: Multi Angle Light Scattering (SEC-MALS) coupled with HPLC or UPLC, Evaporative Light Scattering-UPLC, Fluorescence and Circular Dichroism spectroscopies, Differential Scanning Calorimetry (DSC), Capillary Electrophoresis, SDS-PAGE Electrophoresis and Western Blot technics, Dynamic Light Scattering… Show more Team manager of a group of 7 people in the Analytical Development department. In this role I have the responsibility and management of several complex analytical platforms, in particular: Multi Angle Light Scattering (SEC-MALS) coupled with HPLC or UPLC, Evaporative Light Scattering-UPLC, Fluorescence and Circular Dichroism spectroscopies, Differential Scanning Calorimetry (DSC), Capillary Electrophoresis, SDS-PAGE Electrophoresis and Western Blot technics, Dynamic Light Scattering (DLS).Major Accountabilities and Expertise:- Validation and transfer of analytical methods to commercial manufacturing operations (QC Lab) following the ICH, FDA and WHO guidance - Implementation of Quality by Design approach for analytical methods and vaccines development - Introduce novel technologies/methods for analytical development activities- People management- Laboratory Management- Laboratory Instrument System Owner: management of instrument qualification and maintenance according to GMP requirements- Physicochemical studies for comparability purposes or reference standard-characterization- Characterization of glycol-conjugates, proteins and Outer Membrane Vesicles- Use Sentry Quality Platform for Change Request and Deviation report management. Show less -
Technical Development - Analylicat SpecialistNovartis Vaccines And Diagnostics Dec 2011 - Dec 2013Siena, ItaliaDeep experience and knowledge developed in all the principal matters regarding the Analytical Development, in particular:Analytical methods development, validation and transfer to Quality Control Laboratory.Antigen characterization (protein, Outer Membrane Vesicle, polysaccharides and glycol-conjugates) by use of several chemical-physical technics: Dynamic Light Scattering and Zeta Potential, reverse phase and Size Exclusion chromatography (also coupled with SEC-MALS), UV-Vis… Show more Deep experience and knowledge developed in all the principal matters regarding the Analytical Development, in particular:Analytical methods development, validation and transfer to Quality Control Laboratory.Antigen characterization (protein, Outer Membrane Vesicle, polysaccharides and glycol-conjugates) by use of several chemical-physical technics: Dynamic Light Scattering and Zeta Potential, reverse phase and Size Exclusion chromatography (also coupled with SEC-MALS), UV-Vis and Fluorescence spectroscopies.Knowledge in the visible and sub-visible particles analyses and the main technics used for their detection, such as: Laser Diffraction, Dynamic Light Scattering, Optical Microscopy, Nano Tracking Analyses, Asymmetric Flow Field Flow Fractionation (AF4).Antigen comparability study after manufacturing changes and different clinical phase’s production.Support for investigation related to improvement in manufacturing production, in-process studies, new working seed implementation.Use of the Sentry Quality Platform for Change Request and Deviation report management. Show less -
Phd - Chemical ScienceUniversity Of Naples Federico Ii Nov 2008 - Nov 2011Napoli, ItaliaSynthesis, characterization and applications of novel amphiphilic derivatives of nucleosides
Luca Simeone Skills
Luca Simeone Education Details
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110/110 Cum Laude
Frequently Asked Questions about Luca Simeone
What company does Luca Simeone work for?
Luca Simeone works for Gsk
What is Luca Simeone's role at the current company?
Luca Simeone's current role is Director - Head of Early CMC Development and In-Process Analytics Drug Substance.
What is Luca Simeone's email address?
Luca Simeone's email address is lu****@****gsk.com
What schools did Luca Simeone attend?
Luca Simeone attended Università Degli Studi Di Napoli 'federico Ii', Università Degli Studi Di Napoli 'federico Ii'.
What skills is Luca Simeone known for?
Luca Simeone has skills like Hplc, Cromatografia, Caratterizzazione, Uv Vis, Chimica, Chromatography, Analytical Chemistry, Particle Size, Light Scattering, Analytical Method Validation, Chimica Organica, Quality Control.
Who are Luca Simeone's colleagues?
Luca Simeone's colleagues are Arpit Dixit.
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Luca Simeone
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