SANOFI

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 est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail. About the job    Our Team Within the R&D Global CMC Development organization, the Biologics Formulation and Process Development team is responsible for developing safe, stable, and patient-centric biologic Drug Products and associated manufacturing processes. Our scope of work extends from early development candidate selection through clinical stages, product launch & life-cycle management. The team integrates multiple scientific expertise such as protein stabilization, biochemistry, physical-chemistry and pharmaceutical engineering, and interacts with diverse partners from research, clinical development, or industrial affairs. Main responsibilities Design, supervise or contribute, as required, to formulation development, pre-in use compatibility, formulation robustness and other types of studies throughout product development cyclesDesign, supervise or contribute, as required, to process development studies for routine manufacturing unit operations for injectable dosage forms (e.g. freeze-thaw, mixing, filtration, filling, lyophilization etc.), and in the manufacturing of LST batches within development spaceDevelop experimental plans and execute studies to assess physicochemical stability of biologic drug candidatesDrive scale up and tech transfer activities to clinical and commercial manufacturing sitesWrite and review electronic lab notebooks, experimental protocols, quality documents, experimental and analytical methods, scientific reports and other technical assessmentsCommunicate results and experimental data to internal stakeholders and government bodiesGenerate development reports and contribute to regulatory filings and answers to Health AuthoritiesTake the role of DPTL for 1 or more projects throughout the different product development phases (1-3). This role involves the participation in interdisciplinary teams involving partners within and outside CMC functionFor later stage programs, lead the technology transfer to Industrial AffairsManage technicians, formulation scientists, interns, PhDs, post-docs, as required, and ensure successful contribution and development of the teamEnsure application of Quality and HSE requirements according to global and local guidelinesParticipate in scientific investigational work and write scientific articles and patents, present his/her work in scientific conferencesEvaluate, adapt and implement innovative tools, methods and state of the art practicesContribute to department-related transversal tasks (organizational, HSE, QA, etc.) and working groupsFoster exchange and cooperation with partners within and outside of Global CMC DevelopmentSupport local section head About you Holder of an engineering degree (BAC+5) or equivalent in Process Engineering and/or Chemical EngineeringA thesis in the field as well as physico-chemical knowledge will be appreciated At least 3 years of experience in pharmaceutical and/or chemical process developmentStrong knowledge in the development of "Fill & Finish" processes including the unit operation of freeze drying First experience in the development of drug products for biotherapeutics First experience with management of a team and development of collaborators First experience with project management Scientific leadership skills, ability to contribute to the resolution of issues with scientific rigor, and to promote innovationAbility to work in a multi-cultural professional environment, to navigate across a complex organization, and to establish collaborative networks within the organizations Fluent in written and oral French and English   Pursue progress, discover extraordinary  Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!