Downstream Manager - Night Shift

Sanofi•Toronto, ON

2d•CA$76,200 - CA$110,100•Onsite

About The Position

The B200 Downstream Operations Manager is responsible for the Downstream 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 GMP documentation. This also includes active involvement in B200 project activities from design, and through all stages to commercial production.

Requirements

Minimum bachelor's in science /engineering with 3-5 years of experience in pharmaceutical production with people management responsibility
Experienced with Manufacturing Automation (ex. DeltaV) and electronic batch records will be an asset

Responsibilities

Provide troubleshooting and problem-solving guidance for daily manufacturing issues, and implement preventative/corrective actions
Participate and support the ongoing usage of digital technology (e.g. electronic batch record and e-logbooks) into manufacturing process in the new facility to reduce costs and to improve quality, efficiency and delivery
Develop and execute production schedules for full scale manufacturing, ensure that 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 performance with respect to deliverables using visible metrics and SMS tools
Support execution of operating budget and staffing for operations and related continuous improvement activities
Develop communication approach for Operations topics to ensure milestones are met (escalation, cascading)
In collaboration with QA, 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 to meet requirements for the batch release schedule.
Support internal and external regulatory audits/inspections and coordinate appropriate responses and CAPAs
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
Implement lean management systems and continuous improvement of processes established under SMS.
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
Ensure that employees work within the policies, procedures and regulations including responding promptly to all health and safety concerns or incidents; reportable incidents and accidents are reported; potential safety and health hazards are identified and known by staff and protective equipment are identified and used; continuous HSE awareness and improvement by integrating team with site and IA initiatives
Cooperation with and assistance to the HSE 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
Oversee Downstream operations in Building 200 and provide support to Upstream operations/ Buffer & Logistics when required
Develop and ensure consistency of communication across shifts