Marly-le-Roi 2015 - maintenant1/ Bulk Production Supervisor (1 year - September 2015-2016)
- Team management
- Day to day Plannification (Resources, activites, ..)
- Performance, Quality, EHS KPIs tracking
- GMP QMS responsible (Déviation, Change control, CAPA, Oversight, Audit L1..)
- Continuous Improvement Projects proposal & implementation
Project Manager for all strategical storage projects within the MPU and beyond (multi-sites, multi-MPUs)
- Planning adherence
- Stakeholder Management
- Communication strategy and implementation
- Time & Resources coordination
2/ QA Release & Site conformance - Project Management (6 months - September to March 2017, Marietta, USA)
- Drive the implementation & valdiation of a new SAP GMP Document Management System for the site.
- Write the QC Core File to align with for regulatory requirements
3/ Global Supply Chain Project Manager - Lead time Reduction initiatives (6 months - March 2017 to ongoing)
- FIFO/Priority Lane
- Date accuracy
2015 - 2015Project 1: Following FDA comments, project goal is to reduce and prevent as much as possible viable and non-viable environmental contamination. As SAM support, I have to :
- Review on-site current aseptic practices versus current procedure requirements (Decontamination, material transfer in grade A, aseptic manipulation in grade A, EM testing in grade A, material transfer out from grade A).
- Propose and implement aseptic practice improvements in agreement with production and QA teams.
- Develop a half-day on-site training (theoretical and practical) for new and current GMP technicians. This training package summarizes all the best must-do practices associated with critical aseptic manipulations steps related to grade A.
Project 2: Following FDA comments, as SAM support, I have to manage the implementation of electronic EM sample management to decrease the number of invalid EM testings.
- Manage local MPU project timelines compliance with global timelines.
- Coordinate all steps of implementation with Production, Quality Assurance and Project teams
o Propose in agreement with Global recommendations and Production Facilities Management, a local budget for the MPU.
o Justify the rational of the project electronic hardware order and budget
o Determine key point of contact for training and trainer activities
o Strategize EM Master Data Management for the MPU (2 facilities)
o Implement the strategy
o Follow-up the on-site implementation
Project 3: Following FDA comments, as SAM support, I have to review and create Risk Analysis for EM tests location based on new plan after stop & fix activities in the production facility.
- Review current EM location Risk Analysis against the SOP for EM location.
Mission: Réalisation de la Verification de l'ensemble des deux phases d'installation et de tests opérationels (IV/OV) de skids d'inactivation virale (new IPV) suivant l'AsTM E-2500
- Réalisation des tests de vérification (statiques et dynamiques) et gestion documentaire fournisseur
- Réalisation et gestion des Change controls.
- Réalisation du rapport d’équivalence des skids en collaboraton avec l'équipe C&Q, QA et SME concernés.
NovImmune S.A
- USP Process Development and Optimization Engineer Intern
2013 - 2013Mission: Mise en place d'une plateforme générique de production d'anticorps à but thérapeutique
* développement et optimisation de procédés de Fed-Batch sur les lignées cellulaires CHO leads pour la production d'anticorps propriétaires
* Fed-Batch, DOE analysis, HPLC (ProtA, SEC, IEX), subcloning, purification, Small scale bioreactor culture
Siamed'Xpress
- Projet industriel
2012 - 2013Projet: Mise en place d'une plateforme d'une plateforme de services d'humanisation d'anticorps thérapeutiques.
*Supervisor: Pr Catherine Ronin, CEO
* Mémoire bibliographique, justificatif (matériel et technques), de calculs et économique (viabilité du projet, études d'environnement, de compétitivité, SWOT, Gantt, Resultat et plan de financements)
Biotechnologies - domaine de la Santé - Marché de la santé, Anticorps, Immunologie, Glycobiologie, Génie des Procédés, Génie Biologique, DOE (plans d'expériences), Qualité, Economie, Gestion, Marketing, ..
