Julie CHAMINANT

En résumé

Entreprises

• Baxter International - Research Associate III

  Maurepas 2017 - maintenant Technical lead & Change owner for renal products

• Baxter R&D Europe - Research Associate II

  2014 - 2017 Responsible for:
  - Ensure stability initiation, results review and evaluation, report, submission and deliverables completed per the agreed schedule to meet business needs.
   Actively participate in projects representing Stability Planning team
   Participate in the development of the stability program: Establish the stability plan in agreement with the technical leader, the analytical development and the regulatory affairs
   Participate to the stability plan definition based on the Quality by Design approach.
  - Implement a global statistical approach for limits verification in line with project priorities. Participate in the implementation of SAS web based software
  - Support and ensure relevant stability process, procedure, resources, and schedule are developed and implemented in BAP, CRO and China R&D from technical, operational, logistic and compliance aspects.
  - Utilizes knowledge of existing solution product lines and product stability to support Manufacturing Quality and Product Development organizations in their efforts to improve existing products, manage relevant change controls, resolve issues, and support development of new products.
  - Reviews and approves specifications related to stability and expiration dating.
  
  Essential Duties and Responsibilities.
  1. Without assistance, make sound technical recommendations regarding projects/matters that are more routine than not. Provide some analysis/redesign of key experimental procedures. Independently select techniques and procedures to solve problems within area of responsibility.
  2. Employ appropriate techniques/methods to successfully and independently execute routine assignments within negotiated deadlines. Identify existing alternative methods and technologies for improving existing or new products/processes.
  3. Maintain knowledge of relevant QSR and safety requirements while building knowledge of other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
  4. Recommend appropriate designs, techniques and processes for a specified sequence of tasks where needed.
  5. Contribute to technical feasibility analysis of complex research and design concepts.
  6. Have a working knowledge and understanding of GxP and related regulations and guidance.
  7. Demonstrate ability to apply technical theories and principles to projects within area of expertise for non-routine tasks. Analyze and determine best solutions to non-routine experimental design or research problems with minimal assistance. Accurately assess results for validity and conformance to specifications.
  
  Qualifications:
  • Possess relevant laboratory/technical, writing, and computer skills.
  • Effectively able to contribute on a project team.
  • Demonstrates flexibility and can shift gears comfortably.
  • Ability to objectively assess, organizes, and clearly communicates complex information.
  • Interpret available information and make recommendations to resolve technical challenges.
  • Appropriately prioritize assignments to meet project schedules.
  

• Quality assistance - Analyste Physico-Chimie

  2011 - 2014 Employeur: leader Européen dans la sous-traitance de prestations analytiques pour l'analyse de substances pharmaceutiques (6 laboratoires agréés GMP/GLP/GCLP/GCP selon EMA/FDA/PMDA/ANVISA)
  Missions:
  * Support technologique et scientifique dans le cadre de QC/études de
  stabilité/développement/validation/transfert de méthodes analytiques.
  * Rédaction, data check de documents analytiques en anglais (SOP, rapports, protocoles,
  certificats, procédures).
  * Validation de raw data.
  * Formation du personnel aux méthodes d'analyses.

• AFSSAPS - Stagiaire R&D (méthodes analytiques)

  Saint-Denis 2011 - 2011 Gestion d’un projet de développement de méthodes analytique pour la détection de monomères par GC-MS et FID et d’additifs du plastique par HPLC et UHPLC.
  
  - Etude bibliographique (internet, dossier d’AMM, article scientifiques, site EMEA)
  - Participation à la gestion du projet, commande des réactifs
  - Recherche d’additifs phénoliques (Chap 3.1.13) en combinant les méthodes HPLC décrites à la Ph. Eur. + transfert en UPLC
  - Mise au point d’une méthode de screening en GC-MS (identification de composés volatils)
  - Mise au point d’une méthode quantitative par GC-FID (analyse d’alcanes)
  

• POLYREY Panneaux stratifiés - Stagiaire Industrie

  2008 - 2008 > Thème: Contrôle en continu sur un imprégnateur
  > Mission: régulation d’un appareil de mesure par infrarouge des taux de résine et d’humidité dans un papier et création de calibration afin de respecter les teneurs spécifiées et donc, améliorer la production.
  

Formations

• Faculté Des Sciences Pharmaceutiques, Université Paul Sabatier - Toulouse 3

  Toulouse 2010 - 2011 Master 2
  
  Master 2 Procédés de production, Contrôle et Qualité des produits de la santé - Qualité et Contrôle qualité en Production Pharmaceutique, Procédés appliqués à la fabrication de produits de Santé, Affaires Réglementaires pharmaceutiques

• Université Toulouse 3 Paul Sabatier

  Toulouse 2009 - 2010 Master 1
  
  Master 1 Procédés Physico-Chimiques - formulation, rhéologie, émulsion, procédés de séparation, chromatographie

• Université Toulouse 3 Paul Sabatier

  Toulouse 2008 - 2009 Licence
  
  Licence Chimie option Procédés Physico-chimiques

• IUT Paul Sabatier

  Toulouse 2006 - 2008 DUT

Réseau

• Arnaud DELOBEL

• Brigitte PUJOL

• Clémentine DELANOË

• David BOUREZ

• Edmond LE BORGNE

• Gurvan LE ROUX

• Laure PHILIPPOT

• Rémi DELPLANQUE

• Sébastien GUIMARD