Julie Chaminant

Experience

• 

  ANSM

  Mar 2011 - Aug 2011

  Stage M2

  Sujet: Etudes des intéractions contenant-contenu dans des spécialités pharmaceutiques liquides ou semi-liquides à usage oral ou parentéral.Mission: 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.

• 

  Quality Assistance

  Oct 2011 - Aug 2014

  Analyste Physico-Chimie / Biologie Moléculaire

  - Optimisation et validation de méthodes analytiques (HPLC, SDS-PAGE, IEF, Electrophorèse capillaire)- QC et études de stabilités- Formation de collaborateurs à des techniques d'analyse- Rédaction en anglais de la documentation associée (rapports de validation/stabilités /investigations, méthodes, certificats, procédures)- Respect des guides ICH, SFSTP et des Pharmacopées Européenne et Américaine - Qualité: respect des GMP, GLP- Validation de raw data

• 

  Baxter International Inc.

  Aug 2014 - now

  Technical/Solution leader and change owner for drugs and medical devices solution products.I am supervising Geographical Expansion projects (worldwide) as well as Sustaining projects for a specific solutions portfolio from a technical standpoint. As part of this, my responsibilities are to:- understand and coordinate activities and timelines of a cross-functional team (Regulatory, Marketing, Manufacturing, Stability, Business, R&D, etc....) from product registration to country launch.- Business assessments to launch in the countries- Provide technical expertise and strategy for product design change (raw material, labeling, manufacturing support, regulatory compliance, quality improvement).- Organize, plan and execute sustaining activities and product changes in compliance with current QA/environmental/ regulations and standards- Supervise change owners to get tasks accomplished according to plans, milestones and business needs- Establish, maintain, update and approve Design Control & technical documentation related to projects. - Ensure compliance with international/regional/national regulations for Drugs and Medical Device registrations.- Provide technical support to authorities’ questions and be involved in audit when needed.- Provide resource estimation and forecast.- Ensure good internal and cross-functional communication and regular status update of projects.Qualifications:- Good knowledge of product development stages and life cycle management: development, stability, clinical, registration, process transfer, production, suppliers, customer service.- Ability to manage simultaneously several projects and shift priority according to business needs - Ability to break down technical activities- Working knowledge of international/regional/national regulations and standards Show less Mission:- 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 Baxter R&D sites and CRO 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. Show less

  • Product design owner

    Nov 2019 - now

  • Research Associate III

    Feb 2017 - Nov 2019

  • Research Associate II

    Aug 2014 - Feb 2017