SANOFI

Qualité Sécurité Environnement

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. CONTEXT Sanofi will establish a major active pharmaceutical ingredient company in Europe. The standalone company headquartered in France will combine Sanofi’s API commercial and development activities with six of its European API production sites, located in five countries (France, Italy, Germany, UK, Hungary) and sales in 80 countries. We are looking for an 18 months fixed-term contract: Project leader - State of Art & Regulatory Compliance - EUROAPI (H/F) to support the activities of this future new company (“EuroAPI”).   Act as a project manager for the project named “State of the Art (SoA) and Regulatory compliance remediation plan” of more than 50 actives ingredients substances Contribute with experts to define the remediation strategy based on the conclusions of the state-of-the-art gap assessments versus international guidance such as ICH Q2, ICH Q3, ICH Q11, ICH M7Coordinate the action plans for each API, with internal expertise and subcontractorsEnsure that project planning and budget plan are met As a project manager Establish project planningManage and administrate the project management IT toolOrganize steering committee meetings with EUROAPI and Sanofi identified stakeholdersRecord defined action plansManage the project budget according to annual budget plan and track internal and external expenses accordinglyManage the subcontractors for chemical synthesis, analytical development and expertise, toxicological expertise Project management with a budget of 4-5 M€/year KEY ACCOUNTABILITIES Coordinate the project SoA and Regulatory compliance according to the priorities defined with Sanofi Establish project planning with corporate and site’s expert focal point for each API selected and ensure periodic updatesManage and administrate the project tool chosen within EUROAPIOrganize steering committee meetings with EUROAPI and Sanofi’s identified stakeholdersWrite steering committee minutes to record decisions takenOrganize and lead periodic project meetings with identified stakeholders (EUROAPI corporate and site level)Write project meetings minutes to record action plans defined (what/who/when) Manage the project budget according to annual budget plan and track internal and external expenses accordingly Contribute with site experts to the review of the regulatory gap assessments versus state-of-the-art compliance with regulatory directives (ICH Q2, ICH Q3, ICH Q11, ICH M7) for the selected APIs, specially Definition of starting material (SM)Carry-over and tracking of impurities from SM to APISpecifications and analytical methods of SM and Intermediates (INT)ICH M7 / Mutagenic impurities assessment Contribute with process development and site expert focal points to define the remediation strategy based on the conclusions of the regulatory gap assessments and their criticality State-of-the-art SM definitionIdentification of the impurities of the SMs, Intermediates and API based on batch dataCarry-over of impurities from SMs to APIState-of-the-art of all analytical control methodIn-Silico assessment of SMs, raw materials, impurities detected or most probable from SMs to APICalculation of TTC based on ICH M7 guidelineToxicological testing of the compounds, when neededMost appropriate control strategy for mutagenic impuritiesDevelopment and validation of analytical methods for mutagenic impurities quantification, when needed Manage the subcontractors Ensure the selection of external subcontractors (for chemical synthesis, analytical development and expertise, toxicological expertise)With the site, coordinate external subcontractorsIdentification/characterization of impuritiesSynthesis and/or carry-over of impuritiesToxicology studiesDevelopment and validation of analytical methodsManage contracts, purchase orders and deliverables Assess the need for internal expertise such as Regulatory expertise for gap assessment, regulatory strategyProcess expertise for purge factor calculations, spiking studiesAnalytical expertise for structural analysis, method development PROFILE Experience and Education Engineer diploma or Master at university in Organic Chemistry or AnalyticsProject Management degree or experience would be an advantageFirst experience in the Pharmaceutical Industry in Chemical Development or Analytical Development or Quality or Regulatory Technical skills Project management and corresponding tools would be an advantageScientific Background / Knowledge in Organic Chemistry and/or in AnalyticsFluent in English (is a must)Knowledge of the GMP and notions of the regulatory guidelines such as ICHProficiency in Microsoft office Soft skills Leadership in transverse managementEasy communicatingCommittedRigorous