Reference No. R2770692

Position Title: B100 Operations Manager- Vaccines

Department: B100 cP Upstream

Location: Toronto, ON

About the Job

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 acitivities 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 from a user perspective for B100 project activities and adherence to SOPs, cGMP and HSE procedures.

• Supports the design of B100 relevant operations through remaining stages of project
  
• Review and approve technical and quality related documentation.
  
• Administration of Miscellaneous equipment (user access, periodic review, audit trail management)
  

• Development and ownership of production schedules to support validation, engineering runs and full scale manufacturing
  
• Manages scheduling of preventative maintenance plans, spare parts, BOMs.
  
• Supports development of manufacturing recipes
  
• Supports execution of validation activities related to equipment, process and facilities
  
• Ensures project support and production activities are executed as per defined schedules
  
• Monitors & communicates team performance with respect to deliverables using visible metrics
  
• Supports operations execution on the shop floor (MES, PCS)
  
• Responsible for development and life cycle management of documentation related to manufacturing operations (eBPR, Logs, etc)
  
• Supports 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)
  

• Works with QOOQ, QOSA and RA to ensure compliance with GMP requirements, develop quality continuous improvement initiatives, develop staff quality culture and GMP knowledge
  
• Leads development and maintenance of operating procedures in adherence to global and site policies
  
• Ensures compliance of facilities & equipment; minimize process deviations and environmental incidences, identify root cause and implement corrective/preventative actions.
  
• Supports the development of lesson plans, ensure training is completed in a timely manner. Ensure lesson plans are updated appropriately and training remains current.
  
• Conducts inspections for manufacturing operations (GEMBA, MSV)
  
• Point of contact (lead) for internal/external audits, regulatory inspections, regulatory responses
  

• 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
  
• Contributes to the B100 management team, communicates and co-operates with other departments to obtain consensus and ensure appropriate service levels
  
• Hire new employees and follow company's procedures; responsible for attendance management and time reporting system.
  

• Implement and execute lean management systems established for Bulk; ensures continuous improvement of processes; troubleshoot and lead resolution for manufacturing issues
  
• Identify and lead initiatives to increase process efficiency, quality and/or yield; implements solutions or changes via change control; plans and manages facility and organization improvements
  
• Provides metrics and other reports as requested
  

• Ensures that employees work within the policies, procedures and regulations including responding promptly to all health and safety concerns or incidents
  
• Ensures all critical incidents and accidents are reported to the appropriate authorities; potential safety and health hazards are identified communicated to staff as lessons learned
  
• Ensures that that personal protective equipment and clothing are available and appropriate for the tasks
  
• Ensures 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
  

• 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.
  
• 2-3 years people management + cGMP experience
  

• 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