Deputy Director, Process and Program – CMC

  • Company:
    Sanofi
  • Location:
  • Salary:
    negotiable / monthly
  • Job type:
    Full-Time
  • Posted:
    1 week ago
  • Category:
    Customer Service

Deputy Director, Process and Program Lead – CMC Reference #: 2466380 Department: B100 MTech Location: Toronto, Ontario About Sanofi Pasteur 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. Position Summary: The Deputy Director, Process and Program Lead will report directly to the B100 Manufacturing Technology Director, with the following key accountabilities: Support the development and optimization of process/products in support of B100 new bulk facility licensure and beyond.  This includes improvements in process robustness, bio-burden risk reduction, yield increase and further increase product/process understanding Support establishment of Acel-family expertise and center of knowledge Ensure alignment of CMC strategy and process improvement roadmap through strong and continuous collaboration with key local and global stakeholders Oversee process evolution as part of “APAO2c Wave 2”, that includes technological improvements, removal of animal-derived materials, and process harmonization across sites Establish and lead the Process Improvement group within the Manufacturing Technology project organization, with process and operations-based expertise to support delivery of optimized, robust processes within the correct technical solutions, documentation, trained resources, and operating procedures Additional Key Accountabilites: Technical Oversight and Leadership (45%): Lead a team of 5+ direct reports and a network of indirect report (eg. R&D) to support process improvement activities Define strategy and oversee studies required to support B100 process definition, development and regulatory submission Ensure integration of process improvement (APAO2c) study plan into B100 project and timelines Provide scientific leadership to make the right decisions on the selected process changes Build understanding around process changes as well as for overall process design space to ensure success of B100 licensure and improve yield and consistency of manufacture Anticipate and manage risks appropriately for successful execution and completion of deliverables Review process descriptions and process assessments/impacts including critical parameters Assist in assessment of new technology implementations Support process validation for B100 and future projects Apply effective and structured troubleshooting/ root cause analysis methodology for process problems as needed Assist with discussions and interactions with regulatory agencies as required Strategy and Planning (25%): Define and monitor budget and long-range plan for studies based on the process improvement plan/roadmap, working with MTech, R&D and analytical partners Promote/capitalize on new opportunities for process improvements and innovation Define the plan/roadmap for study program up to B100 regulatory submission and beyond for APAO2c Wave 2 process changes/improvements Transversal Expertise and Management (30%): Communicate and report to site and global leadership and governance committees on a regular basis Collaborate with site multi-functional team (R&D, Manufacturing Technology, Quality, Analytical Process and Technology, etc) and experts in the Sanofi network Ensure collaboration with other product/process improvement projects for Component Pertussis, Diphtheria and Tetanus for integration within the project and characterization scope Connect with global strategy to ensure harmonization and alignment with process improvement roadmaps Health, Safety and Environment: Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act. Education:  M.Sc or Ph.D  Experience: Minimum 8-10 years direct experience in biotech R&D, manufacturing, and quality environments/ organizations 5+ years demonstrated leadership in behavioral competencies and management Sound knowledge in biochemistry and protein chemistry Expertise in chromatography and other protein purification techniques Sound knowledge in microbial fermentation and upstream processes is an asset Demonstrated understanding of current Good Manufacturing Practices, Health and Safety, high quality standards, industry standards and their application to the manufacturing process Process validation experience Effective in trouble-shooting and root cause analysis Strong technical writing Excellent communication and transversal management skills Good understanding of regulatory requirements and document preparation Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, 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 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. Sanofi, Empowering Life At Sanofi diversity and inclusion are foundational to how we operate and are embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences.  We recognize that  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 employees, patients and customers.