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Manager – BioProcess R&D Operations

SANOFI

This is a Contract position in Toronto, ON posted May 6, 2018.

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. Job Overview The Manager will serve as the subject matter expert (SME) for FUE (facilities, utilities and equipment) commissioning, qualification and validation as well as for cGMP quality compliance. The incumbent will lead and manage activities of platform teams or transversal groups, provide expertise on relevant scientific and technical subjects and help develop and/or implement strategic initiatives. The manager will lead the execution and the timely achievement of milestones for project/activities. Key Responsibilities Oversee the planning, preparation and execution of validation related activities and documentation for BioProcess Research & Development (BRD) GMP equipment, utilities and facilities. Contribute to the satisfactory compliance of BRD towards current GMP and other regulatory agency requirements, as well as to BRD’s efforts towards continuous improvement, implementation of novel technologies, initiatives and equipment. Liaise with stakeholders and serves as the SME regarding validation and quality compliance issues on behalf of BRD. Supervise, train, motivate and empower technical personnel to perform the experimental and processing tasks. Ensure good teamwork and provide high quality deliverables, such as reports and other items to project teams and other partners within agreed timeframes. Ensure compliance of direct reports with quality requirements, policies and procedures as well as with meeting documentation requirements such as validation study plans, criticality assessments, SOPs, validation reports etc. Provide leadership for data input, standardized formats, database creation and management, and implementation of corporate standards. Share information and harmonize development within and between BRD platforms, project teams and other stakeholders such as Sites Quality Operations, Research & Development, Facilities Management, etc. as required. Prepare project summary reports, internal and external presentations, position papers and other documentation as required. Supervise and monitor compliance with labour and health & safety legislation to ensure that employees work safely and compliant with regulations. Required Qualifications Degree in Chemical Engineering, Biology, Biochemistry, or Life Sciences Five (5) years of relevant work experience within the biopharmaceutical industry In-depth knowledge of the principle discipline

– validation and biopharmaceutical industry compliance (i.e. current industry standards and practices, and process/environmental engineering) Working knowledge of Microbiology, Biochemistry, Chemical Engineering, Fermentation, Cell and Viral Culture, and Formulation & Stability In depth knowledge of experimental work and data analysis Good statistical skills and scientific writing Ability to manage a team and employees development Effective oral and written communication skills, and innovative thinking Familiarity with strategic planning, balanced judgment and risk analysis 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 LinkedIn: #LI-SP Sanofi Glassdoor: #GD-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