Raw Materials and CMM Professional Title: Raw Materials and CMM Professional Reference No.R2623173 Location: foronto, Canada Sanofi Pasteur: The world’s leading vaccine company Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering, We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Mission The role of the Raw Materials and CMM professional is to provide technical expertise for continuous improvement of all manufacturing process and support shop floor production on a daily basis to reach industrial execllence. The Industrialization - Life Cycle Management team in the Centre of Expertise leads the validation activities and technical activities related to raw materials, filters, single-use systems, and extractables & leachables (E&L). Key accountabilities + Ensure robustness and continuous improvement of manufacturing processes. Strengthen process and product knowledge through process criticality analysis , presence at the shop floor and technical assistance to current manufacturing processes. Stay abreast of current advances in area of technical expertise. + Drive troubleshootingyinvestigation related to his/her products/process. Supports the manufacturing areas with complex issues, product impact assessment, and root cause analysis. * Contribute to strategy related to specific project, process validation, scientific and technological assessment and inspection readiness. Drive the implementation of actions plans. ‘+ Generate and drive CCRs to implement material or process changes. Generate and drive "APAs to implement corrective or process improvement initiativ + Share knowledge and area of expertise to support business. Contribute on Project Teams, as MTech representative, Interface with other MTech areas and other departments (e.g. Vaccine Industrial Affairs (Bulk Manufacturing), QO Validation, QO Shop Floor, QC, GEM, R&D, RA) for assistance.‘+ Contribute to maintain compliance with all CGMP regulatory standards and Sanofi Pasteur policies and procedures. Contribute to quality improvements and participate in inspection and regulatory responses, «Assist in supervising and training process support staff in managing continuous performance improvement. Participate in regular staff and technical meetings, and maintain open lines of communication Description of Activities + Author and review material specifications and user requirement specifications. ‘* On behalf of Mtech, manage investigations related to raw materials, ‘* Contribute to the site Critical Materials Management (CMM) project by creating change control plans, define critical material attributes and key material attributes (CMA/ KMA), support the regulatory submission documentation, ‘+ Supplier change notifications: Author risk assessments, validation protocols and reports to support troubleshooting/investigations related to raw materials, consumables (including single-use systems and filters) issues. ‘+ Design and manage extractables and leachables (F&L) studies to support new in-process materials, drug substance containers, primary packaging components, and issues around current materials. Author protocols and reports related to E&L studies. ‘+ Breadth of responsibility: site level Key dimensions ‘+ No direct report Provide guidance to others on a routine basis, + Key indicators: Ensure timely resolution of raw material investigations and implementation of action plans. Ensure inspection readiness and strong support during regulatory inspections. ‘+ Freedom to act: Ensure robustness and continuous improvement of manufacturing processes. Key business partner for any process related decision. Education and experience + Specific degree, duration of experience: MS (Science/Engineering) or Ph.D (Science/Engineering) with 3 years related experience, OR BS (Science/Engineering) with 7 years of related experience. Competencies * Cooperate transversally (collaborate effectively across the organization to positively impact business results) ‘+ Strive for results (seck ongoing improvement of process performance to create sustainable added value)‘+ Make decisions (accountable for any process-related decision) ‘+ Commit to costumers (understand customer expectation to ereate positive impact) Key technical competencies and soft skills: + Knowledge of 1 or more technical areas of manufacturing (fermentation, cell culture, purification), problem-solving. Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request. Thank you in advance for your interest. Only those candidates selected for interviews will be contacted. Sanofi, Empowering Life #GD-SP #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. ‘We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.