The Operations Manager is responsible leadership of the relevant manufacturing operations in compliance with cGMP including Media, Upstream, Downstream, Adsorption and WnS for our new facility . The Manager is responsible for guiding and coaching management and union staff and to support as a subject matter expert (SME) with respect to execution of all operations in a GMP environment. The Operations Manager will also monitor processes that impact multiple areas, for example, the Utilities System, Waste Treatment systems, HVAC system. The Operations Manager will lead key project and manufacturing initiatives for our new facility to provide direction and ensure the key strategies are implemented to support the project phase and transition into manufacturing start-up.
- SME and operational lead supporting the design of the new facility relevant vaccine upstream and downstream manufacturing operations through all stages of project from process design through commissioning and qualification to engineering runs and facility start-up.
- Technical expertise in biologics bulk manufacturing (upstream, downstream, formulation)
Planning and Execution
- Lead key manufacturing initiatives for the new facility building project to achieve project deliverables and ensure readiness for manufacturing start-up.
- Provide input and support development of operating budget, staffing and resource allocation for operations and project related activities.
- Support the development of workforce planning and organizational structure to support project and manufacturing activities (upstream, downstream, Adsorption, Media, WnS processes) from design to start-up
- Provide strategy and guidance for the facility commissioning and qualification and start-up
- Lead team in the development of operational procedures, training and documentation cGMP Compliance & Quality
- Ensure compliance of facilities & equipment design adhering to GMP regulations and global policies. Develop quality continuous improvement initiatives, develop staff quality culture and GMP knowledge
- Support the development of the quality framework for change control, CAPA, and deviation management for digital manufacturing systems (MES/eBPR)
Continuous Improvement/Health and Safety
- Implement and execute lean management systems established for Bulk; ensures continuous improvement processes
- Identify and lead initiatives to increase process efficiency, project risk mitigation and project performance
- Accountable for a safe workplace by supervising and monitoring compliance with employment and health & safety legislation
- Drive safety mindset in the facility operations team through engineering and process design, risk mitigation and modelling safe behaviors
Scope and dimensions
- Responsible for up to 4-6 managers
- Organizes and develops staff to ensure a high performing team; establishes, monitors and provides individual feedback on staff objectives; ensures training of staff according to training plans and to continue to develop their competencies; coach staff on personal development goals and document follow up
- Oversees specific/general areas of operations in the new facility
Education and Experience
- Minimum BSc in Microbiology/Biochemistry/Related Science with experience and additional business and management training.
- Preferred post-graduate in Microbiology/Biochemistry/Engineering or Related Science
- 5-10 years in biologics manufacturing with experience leading high performance teams.
- Experience with commissioning, qualification and validation within a GMP environment
- Technical background (process oriented) in the biologics or biopharmaceutical industry
- Experience with the start-up of a new facility or process in a GMP organization
- Proven leader with experience in building a high performing team
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 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
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.