SANOFI

Recherche & Développement

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.

. Le contenu du poste libellé en anglais car il nécessite de nombreuses interactions avec l'étranger, l'anglais est la langue de travail. Sanofi Vitry-sur-Seine, located 10 minutes from Paris, is one of the most innovative sites within the group with more than 2000 employees. With an ultra-modern multi-products cell culture and purification plant, the Biolaunch, the site gathers research, development and manufacturing of biological drug substances as monoclonal antibodies. Diversification continues to bring new products to Vitry-sur-Seine and the expanded site portfolio continues to create new opportunities. DEPARTMENT DESCRIPTION: The Global Manufacturing Sciences and Technology (MSAT) is a center of excellence in manufacturing and process sciences and as such is the keeper of the body of manufacturing process knowledge. It is a multi-disciplinary function that provides expertise in process and analytical sciences; manufacturing sciences, process modeling, trending and statistical analysis; process validation and technology transfer. The Global MSAT organization is the seeding ground for technical and scientific talent that executes their work in matrix organization. Furthermore, the Global MSAT is providing cross-functional training and development, and is the portal for collaboration with many different organizations including process development and operations. In that scope, Global MSAT is responsible for: Providing on-the-floor technical and scientific supportProviding expertise in process/product-related investigationsOverseeing and leading data management, monitoring and statistical analysisOwning technical transfers and process validation Defining and maintaining the product control strategyOwning comparability and product characterizationIdentifying commercial process/product life cycle improvementsIdentifying and driving implementation of improvements to maximize throughput and capacity utilization Within the Vitry-sur-Seine local Manufacturing Sciences And Technology (MSAT) organization, we are looking for an experienced Downstream Process Engineer to join our expanding team. KEY RESPONSIBILITIES: Manages process fit-gap assessment in tech transfer team for purification, formulation and filling processes and identify areas requiring mitigation via process adaptation or facility modificationLeads process validation including strategy definition, the execution follow-up and documentation managementDefines and maintains the process control strategy for DSPRoutinely monitors DSP manufacturing process and identify trends and resolves using her/his expertise and site resources, where possible, or escalate to MSAT governing body requiring additional expertise and resourcesLeads DSP process related complex problem investigation at the site by using solid process understanding and use of scientific and engineering principles and practices and facilitates generation of practical solutionsAs an downstream processing SME, provides technical support during health authority inspectionDrives continuous process robustness and improvement in order to make processes more cost effective at the same time maintaining quality and HSE requirementsDevelops connection within global MSAT in international context BASIC QUALIFICATIONS: Master’s Degree or PhD in engineering or science with minimum 5 years of experience in cGMP manufacturing environment or biologics process development REFERRED QUALIFICATIONS: Strong experience in process development, process characterization, technology transfer and process validation in bio-manufacture industryKnowledge of purification technologies and operationsKnowledge of viral clearance of purification processesExperience with automated protein purification chromatography and UF/DFExperience with DeltaV Process Control systemExperience 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 #LI-FR