The B100 operations manager is responsible for the relevant manufacturing operations in compliance with cGMP according to their specific production area (upstream, downstream, MWS, etc). The manager is responsible for the daily activities of unionized staff in a cGMP facility in compliance with company policies. This includes responsibility for the scheduling and execution of all operations with adequate level of GMP documentation. This includes support for B100 project activities and adherence to SOPs, cGMP and HSE procedures.

Technical (20%)

• Support the design, startup, and troubleshooting of B100 process and equipment operations through all stages of project (URS, IQ/OQ, Engineering and Consistency runs, full operations).

• Review and approve technical and quality related documentation. (PNID, qualification, validations, and design documents.

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

Planning and Execution (25%)

• Develop and execute production schedules from project through full scale manufacturing, ensure that project support and production activities are executed as per defined schedules.

• Lead operations team execution on the shop floor for equipment, processes, and facilities. Monitor and communicate team and project performance with respect to deliverables using visible metrics.

• Support development of operating budget and staffing for operations and project related activities.

• Develop communication approach for operations topics to ensure project milestones are met (escalation, cascading).

cGMP Compliance & Quality (20%)

• In collaboration with QOOQ and QOSA, ensure compliance with GMP requirements, develop quality continuous improvement initiatives, develop staff quality culture, and GMP knowledge.

• Ensure that all Operating Procedures, training plans, and manufacturing documentation are current, developed in adherence to global and site policies, and completed in a timely manner.

• Through appropriate shop floor oversight, ensure that facilities & equipment are compliant, and that process deviations and environmental incidences are addressed in a compliant manner.

• Support internal and external regulatory audits/inspections and coordinate appropriate responses.

People and Development (20%)

• Organize and develop staff to ensure a high performing team. Provide individual feedback on staff objectives and development, coaching each team member on personal development milestones.

• Contribute to the B100 Operations management team, communicate and co-operate with other departments to obtain consensus and achieve project and operational goals.

• Hire and on-board new employees, apply company’s discipline procedures when applicable, manage team attendance and performance against established criteria.

Continuous Improvement (10%)

• Implement lean management systems and continuous improvement of processes established for Bulk.

• Identify and lead initiatives to increase process efficiency, quality and/or yield. Implement solutions or changes via change control, plan and manage facility and organization improvements.

• Provides metrics and other reports as requested, including the scheduling of PM plans, spare parts, BOMS.

Safety (5%)

• Ensure that employees work within the policies, procedures and regulations including responding promptly to all health and safety concerns or incidents; critical incidents and accidents are reported to the appropriate authorities; potential safety and health hazards are identified and known by staff and that protective equipment and clothing are required and are used; continuous EHS awareness and improvement by integrating team with site and Bulk initiatives.

• Cooperation with and assistance to the EHS management and Joint Health and Safety Committee in carrying out their functions.

• Shift size : up to 20 Union staff

• Oversees specific area of operations in Building 100

• Develop and Ensure consistency of communication across shift

Key Requirements:

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

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

• Cooperate transversally

• Act for change

• Commit to customers

• Strive for results

• Make decisions

• Lead teams

• Develop people

• Think strategically

Pursue Progress.

Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!

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.

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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.