Reference No. R2729373

　　Position Title: Manager, Diphtheria Tetanus Bulk Manufacturing

　　Department: DTPPD Bulk

　　Location : Toronto, Ontario

　　Sanofi Vaccines

　　Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.

　　At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

　　Position Summary:

　　The Process Upstream Manager, DT&PPD Production serves as the main technical process leader for the area related to equipment, quality, and process in Diphtheria and Tetanus fermentation. The role provides leadership on improving overall performance for the upstream fermentation operations. This includes safety, compliance, business process improvements and operational activities.

　　Reporting to the Deputy Director, B90 Diphtheria and Tetanus Bulk Manufacturing, the Process Upstream Manager provides direction to the operational team, delivers supply according to schedule and develops and implements short and medium term strategic plans for the upstream manufacturing team. The Process Upstream Manager works closely with B90 Managers to deliver adherence to the production schedule, timely management of Deviations, CAPAs and CCRs to ensure continuous compliance with safety standards and cGMPs.

　　The Process Upstream Manager acts as a core member of the B90 Bulk APT, collaborating with a cross-functional team to achieve the APT’s objectives.

　　Key Responsibilities:

　　Leadership/Communication:

　　Provide leadership to a diverse group of employees, manage the team by organizing their daily activities, following up, communicating the plan in advance, ensure cohesion of the team, celebrate with the team.

　　Knowledge of Excel, Word, Outlook and PowerPoint.

　　Daily presence with the team on the shop floor is required.

　　Cascade information to and from staff, through verbal (+QDCI for example) and written communication.

　　Safety:

　　Reinforce safety mindset of the shop floor, identify potential near-misses and other hazards and fix before event occurs, develop checklists to standardize routine safety verifications and good shop floor behaviors.

　　Experience in lean manufacturing management systems.

　　Strong knowledge and familiarity with cGMP practices, with context of pharmaceutical/biologicalmanufacturing.

　　Quality:

　　Ensure SOPs are current and followed, ensure BPR and logbooks are accurate and reviewed with minimal delay, ensure root cause of process or environmental deviations are identified, ensure staff training is complete and up to date.

　　Consistently implement corrective and preventive actions, as well as process improvements.

　　Work with the staff to decrease the human error deviations: develop ownership of the deviations, improve the organization around the tasks for full mistake proof solutions and improve checklists.

　　Experience in validation, aseptic processing, sterilization & disinfection.

　　Delivery/Scheduling:

　　Understanding of key activities including formulations and sterile operations.

　　Assure the production plan and schedule daily to 4 months for the upstream area including indirect activity for media washing and sterilizing, in conjunction with the direct activities of fermentation, taking into account the harvesting detoxification and purification schedule.

　　Support execution of project activities to meet the business needs of the site.

　　Cost:

　　Develop staff to assure a high performing team, finding ways to reduce overtime, provide individual feedback on staff objectives, assure adequate cross training of staff.

　　Own the fermentation suites and ensure equipment/area is maintained.

　　Provide troubleshooting and problem-solving guidance for daily manufacturing and project issues, and implement preventative/corrective actions.

　　Support development of operating budget and staffing for operations.

　　Involvement:

　　Involve and co-operate with other departments to obtain consensus and assure appropriate service levels.Key Requirements:

　　Preferred post-graduate in Microbiology/Biochemistry/Engineering or Related Science.

　　Minimum Honors BSc in Microbiology/Biochemistry/Related Science with experience and additional business and management training.

　　36 months in Manufacturing in a pharmaceutical clean room environment.

　　4 years of experience in managing or supervising a department with more than 5 employees.

　　Minimum 5-7 years of previous relevant experience is a minimum requirement.

　　Strong communication and influencing skills, project management skills, problem solving, strong leadership and management capability.

　　Relevant industries: Vaccine or Manufacturing Pharmaceutical company.

　　Pursue Progress.

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　　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.

　　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.