Alex MEDEVIELLE

Experience

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  SDIS 11

  Jun 2014 - Aug 2014

  Sapeur Pompier Volontaire Nageur Sauveteur

  Sapeur Pompier Volontaire Saisonnier avec la qualification de Nageur Sauveteur affecté à la surveillance des plages de la commune de Saint Pierre la mer. Secourisme et sauvetage en mer.

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  ITAV - Institut des Technologies Avancées en sciences du Vivant

  Jul 2015 - Aug 2015

  Stagiaire

  Intégré dans l'équipe IP3D (Innovation for the study of tumor cell Proliferation in 3D) sous la direction du docteur Valérie LOBJOIS j'ai participé à l'étude de la combinaison d'un inhibiteur de la Topo-isomérase avec un inhibiteur de la déacétylase sur la prolifération cellulaire, notamment tumorale. Pour cela j'ai mis en oeuvre des techniques de culture cellulaire humaine, de cytométrie en flux et de spectrophotométrie UV.

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  CHU de Toulouse

  Oct 2015 - Mar 2016

  Externe en pharmacie des hôpitaux de Toulouse, mon rôle était de faire le lien entre les équipes de pharmacie clinique et les médecins des services de Néphrologie en leur apportant une expertise pharmaceutique. J'effectue également des conciliations pharmaceutiques, pour cela je réalise des entretiens pharmaceutiques avec les patients et j'évalue leur traitement en concertation avec l'ensemble des professionnels de santé concernés avec pour objectif une prise en charge optimale de tous les patients. Show less

  • Externe en Pharmacie

    Jan 2016 - Mar 2016

  • Externe en Pharmacie

    Oct 2015 - Dec 2015
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  LFB

  Apr 2016 - Jul 2016

  Stagiaire - Innovation Thérapeutique

  Development and validation of FPLC (Fast Protein Liquid Chromatography) process to separate and purify specified antibodies from Human plasma. Analysed of the antibodies by ELISA, FastElysa, SDS-Page, UV...

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  CHU de Toulouse

  Aug 2016 - Sept 2016

  Externe Litige Qualité

  Externe en pharmacie en charge du traitement des Litiges Qualité concernant les Dispositifs Médicaux au CHU de Toulouse.

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  Ferring Pharmaceuticals

  Jan 2017 - now

  As global Subject Matter Expert (SME) for analytical methods, I support the Ferring manufacturing network (13 manufacturing sites + external laboratories) by:• Leading complex analytical troubleshooting (DMAIC, PPS, FMEA...).• Leading analytical transfers between Ferring sites or third-party manufacturers. • Managing the introduction of new analytical technology from development, validation, registration and actual implementation (NIR, Raman, UPLC...).• Planning and performing analytical maintenance/development work for analytical methods for various drug substances and drug products.• Providing strategic and operational advice to Technical Operations management to define strategy for analytical methods, stability and validation.• Leading/Participating in cross-functional teams to create, maintain and implement SOPs, guidelines, tools to facilitate and structure working processes within the analytical area in Ferring Show less • Support Ferring manufacturing network (13 sites over the world) with analytical technical expertise and troubleshooting.• Lead, manage or participate in analytical technology introduction projects within Ferring manufacturing network• Lead, manage or participate in Technology Transfers of analytical methods between Ferring sites or to/from third-party manufacturers• Plan and perform analytical maintenance/development work for analytical methods for both drug substances and drug products• Support the Director in driving the strategy for analytical methods, stability and validation providing strategic and operational advice to Technical Operations management• Participate in cross-functional teams to create, maintain and implement SOPs, guidelines, tools to facilitate and structure working processes within the analytical area in Ferring• Support, facilitate or manage strategic and cross-functional projects/ tasks Show less Inside the QC department of Ferring, I am in charge of:- Implementation of new NIR (Near InfraRed) assay analytical method: Development, Validation, Transfer, Qualification, SOP and ATM writing, Training of analysts, skip testing rational...- Heavy analytical investigations which involved Production, Quality Assurance and Regulatory departments. - Regulatory support regarding analytical questions : CTD writing (3.2.P.5.2 and 5.3), rational building, answer to authorities...I also has the opportunity to work with the process development department on 3D printing and tableting projects. Show less In charge of the FT-NIR implementation in quality control department, my missions were:- Qualification (IQ/OQ/PQ) according to 21CFR part 11 and Data integrity principles. - Lab to Lab transfer. - Complementary studies: DoE (design expert), statistic analysis, environmental impact...In parallel I also lead 3D printing project (solidwork modelling, Slic3R, Cura...) with pharmaceutical applications and prove of concept for the robotisation of production line with matlab (image processing, deep learning, neural network). I also learned and used development tableting machine (Styl'one from Medelpharm). Show less

  • Global Analytical SME - Center of Expertise Analytical Processes

    Apr 2024 - now

  • Research Scientist - Center of Expertise Analytics

    Jun 2022 - Apr 2024

  • Associate Research Scientist - Center of Expertise Analytics

    Sept 2021 - Jun 2022

  • QC Specialist - Project, investigation and validation

    Jul 2017 - Sept 2021

  • Intern - Pilot Plant / Quality Control department

    Jan 2017 - Jul 2017