Sanofi Group Technical Manager, Vaccine Downstream Industrialization (new vaccine production facility) in Toronto, Ontario
The B100 MTech Technical Manager, Vaccine Downstream Industrialization, will work with the Downstream Lead, with the following key accountabilities:
Secure optimized and robust industrialization of vaccine product downstream process in the new B100 bulk manufacturing facility
Deliver a strong and comprehensive characterization and validation package in collaboration with the MTech B100 team and other key players (ARD, AP&T, BRD, QC, etc)
Support the design and qualification of downstream process equipment to ensure full compliance to process specifications/ requirements, industry standards and quality aspects
Ensure effective and logical process adaptation in the framework of a new facility
Deliver on Design and Qualification Phases
Review process flow diagrams, mass balances and process descriptions and process assessments/impacts including critical parameters
Participate in Design Qualification for process equipment to ensure alignment with process requirements and specifications
Review equipment design and automation (FS, DDS, P&ID, GA drawings, etc)
Assess new technology implementations , including closed systems and single-use technology
Support C&Q activities: including (but not limited to) pre-FAT inspections, FAT, SAT, IQ, and OQ of the applicable process equipment/systems in conjunction GEM, Operations and Quality/validation
Downstream Process Development, Optimization and Validation
Oversee design and execution of scale-down of manufacturing processes to support validation and characterization.
Demonstrate adequacy of the solutions selected with the process needs.
Collect and properly interpret data generated from execution of studies.
Perform process development and validation with industrial equipment, that includes in-line dilution systems, chromatography systems, columns, centrifuges, ultra-filtration and filtration systems
Execute process validation studies, developing detailed validation and study protocols/reports related to process, cleaning, decontamination, and related supportive studies.
Assist in sample and material management during engineering, technical and consistency batches
Provide training on operation/use of process equipment (within areas of equipment specialization)
Ensure process knowledge transfer throughout all phases of project execution up to and including consistency lots and regulatory preparation
B100 MTech Technical Manager, Vaccine Downstream Industrialization will work in an office, manufacturing and lab environments including full gowning/PPE during manufacturing phase (technical and consistency batches)
Some travel required in North America and Europe (planned travel 5%)
Minimum BSc or BEng in Chemistry, Chemical Engineering, Biochemistry, or related field
Minimum 3 years direct technical experience in biotech R&D and/or quality within manufacturing, biopharma or life science industry (GMP)
Hands-on experience with chromatography systems, protein purification, TFF systems, centrifuges, filtration systems and single-use technology
Experience in process industrialization of a biopharm/pharma product
Min 1 year Equipment and/or process validation experience in a GMP or highly regulated environment
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.
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
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.
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