Upstream Operations Manager- Vaccines

The B200 Upstream Operations Manager is responsible for the Upstream manufacturing operations in compliance with cGMP. 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 also includes active involvement in B200 project activities from design, and through all stages.

Technical

• Participate in the design, commissioning, startup, and troubleshooting of Upstream process (Eggs Receiving, Inoculation, Incubation, Cold boxes, Harvest) and equipment operations through all stages of project (C&Q, IQ/OQ, Engineering and Consistency runs, full operations)

• Manage the procurement process and readiness of small equipment within Operations for engineering runs and start-up

• Review and approve technical and quality related documentation. (P&ID, IOQ, PPQ, and design documents.

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

• Participate and support the incorporation of digital technology (ex. electronic batch record and e-logbooks) into manufacturing process in the new facility to reduce costs and to improve quality and delivery capability

Planning and Execution

• 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 from design to start-up

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

cGMP Compliance & Quality

• 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 and environmental deviations are addressed in an expedited and compliant manner.

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

People and Development

• 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 B200 Operations management team, communicate and co-operate cross-functionally to achieve project and operational goals.

• Hire and on-board new employees, manage team attendance and performance.

• Develop and oversee technical training plan to ensure training compliance for all shop floor staff

Continuous Improvement

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

• Challenge status quo; 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

• Provide metrics and other reports as requested, including the scheduling of PM plans, spare parts, BOMs

Safety

• 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

• Ensure complete and comprehensive safety training of staff

• Must have full understanding of all Hazard and Operability Analysis (HAZOP) and awareness of all Hazard Identification (HAZID) pertaining to Operations equipment and processes

• Shift size : 10-40 Union staff

• Oversees Upstream of operations in Building 200 and provide support to Downstream operations/ Buffer & Logistics when required

• Develop and Ensure consistency of communication across shifts

• 10% travel to international company sites and to both domestic and international equipment manufacturers may be required

• This position is an afternoon shift position. It requires working on the day shift during the first 3 months of the training period. Once Engineering runs start they will be required to work on the afternoon shift full-time.

About You

Education and Experience:

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

• Minimum BSc in Microbiology/Biochemistry/Engineering or Related Science with additional business and management training

• At least 5 years experience in pharmaceutical production, with people management responsibility

• Experienced with Manufacturing Automation (ex. DeltaV) and electronic batch records will be an asset

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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.​

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