SANOFI

Ingénierie / Méthode

La vocation de Sanofi est d’accompagner celles et ceux confrontés à des difficultés de santé. Entreprise biopharmaceutique mondiale spécialisée dans la santé humaine, nous prévenons les maladies avec nos vaccins et proposons des traitements innovants. Nous accompagnons tant ceux qui sont atteints de maladies rares, que les millions de personnes souffrant d’une maladie chronique. Sanofi et ses plus de 100 000 collaborateurs dans 100 pays transforment l’innovation scientifique en solutions de santé partout dans le monde. Sanofi, Empowering Life, donner toute sa force à la vie. Chez Sanofi, la diversité et l’inclusion sont au cœur de notre fonctionnement et sont intégrées à nos Valeurs fondamentales. Nous sommes conscients que pour exploiter véritablement la richesse que la diversité nous apporte, nous devons faire preuve d’inclusion et créer un environnement de travail où ces différences peuvent s’épanouir et être développées pour améliorer le quotidien de nos collègues, patients et clients. Nous respectons et valorisons la diversité de nos collaborateurs, leurs parcours et leurs expériences dans un objectif d’égalité des chances pour tous.

Sanofi Vitry-sur-Seine est l’un des sites les plus innovants du Groupe, avec plus de 2 000 collaborateurs. Doté d’un outil de production ultramoderne, le Biolaunch, le site maitrise à la fois les activités de recherche, de développement et de fabrication de produits de biotechnologies. Les pathologies que nous traitons ?  Le cancer, les maladies neurodégénératives et les maladies cardiovasculaires. MISSION DESCRIPTION Job Reasons : As part of a new product introduction at Sanofi Vitry-sur-Seine, in Biolaunch a multi-products cell culture and purification plant of biological drug substances, the local Manufacturing Sciences And Technology (MSAT) organization is looking for an experienced Upstream Process Engineer to support process transfer & validation activities as well as providing strong Upstream expertise.   Main Functions : Manages process fit-gap assessment in tech transfer team for upstream and identify areas requiring mitigation via process adaptation or facility modificationLeads process validation including strategy definition, documentation management (protocols and reports) and execution follow-upDefines and maintains the process control strategy for USPMonitors USP manufacturing process, identify trends and resolves using her/his expertiseLeads USP process related complex problem investigation by using solid process understanding and use of scientific and engineering principles and practices and facilitates generation of practical solutions REQUIRED EXPERIENCE Master’s Degree or PhD in engineering or science with minimum 5 years of experience in cGMP manufacturing environment or biologics process developmentStrong experience in process development, process characterization, technology transfer and process validation in bio-manufacture industryExperience in Mammalian cell culture including seed train, large scale bioreactors and cell culture clarificationExperience in cGMP and good understanding of regulatory requirements for biologics manufacturingStrong knowledge in data management and statistical analysisProficiency with MS Office (Excel, Power Point, Word)Ability to make a significant contribution to cross-functional project teams through technical expertise and scientific creativityTeam player, ability to work effectively in a highly collaborative and dynamic environmentExcellent communication skillsFluent in French and English MAIN PURPOSES OF THE MISSION Support process transfer & validation activities as well as providing strong Upstream expertise as part of a new product introduction at Sanofi Vitry-sur-Seine.   MISSION CONTEXT In Biolaunch, a multi-products cell culture and purification plant of biological drug substances plant, the local Manufacturing Sciences And Technology (MSAT) organization is looking for an experienced Upstream Process Engineer to support process transfer & validation activities as well as providing strong Upstream expertise.   Strong time constraints are associated with this mission and the interfaces to be managed are numerous. Functional management to be anticipated for some technical project teams. INTERFACES Many interactions in international context: Global MSATManufacturing BiotechLogisticQuality ControlQuality AssuranceRegulatory Le descriptif est en anglais, car le candidat doit être fluent pour occuper le poste.