Operations Supervisor

at  Centre for Commercialization of Regenerative Medicine

ABOUT CCRM:

CCRM, based in Toronto, Canada, is a public-private partnership that is developing and commercializing cell and gene therapies and regenerative medicine-based technologies. We are leveraging our network of academics, industry partners and investors to tackle significant industry challenges and advance our most promising technologies to the market to meet the needs of patients. For more information about CCRM, please visit our website at ccrm.ca.

REQUIREMENTS:

• Bachelor’s degree in science (biological or life sciences, biotechnology or microbiology), master’s degree is preferred.
• 5-7 years of experience working in a GMP environment, with supervisory experience.
• Knowledge and expertise in some or all the following manufacturing areas: cell expansion, cell culture, fill/finish, final formulation of cell products.
• Solid understanding of Health Canada/U.S. Food & Drug Administration (FDA) GMP regulations and quality assurance principles.
• Experience with electronic quality management systems.
• Team-oriented, analytical, organized, detail-oriented, self-motivated, and able to multi-task are essential.
• Drive for results is essential.
• Strong English written and verbal communication skills.
• Strong working knowledge of Microsoft Office programs.
• Proven track record of writing GMP documents (i.e., SOPs, validation procedures).

ROLE SUMMARY:

As Operations Supervisor at the CCRM, you will join the team at the Centre for Cell and Vector Production (CCVP), a Good Manufacturing Practices (GMP)-compliant facility manufacturing regulated products to enable clinical translation of cell and gene therapies. You will provide technical expertise and will work with the team to define and execute project tasks. You will be an operations leader in bringing new and innovative products to market to enable life-saving advances in cell and gene therapy and regenerative medicine. Your role will act as support to the Operations Manager.

RESPONSIBILITIES:

• Ensure that all daily and weekly production schedules are met.
• Ensure daily presence on shop floor and conduct routine walk-throughs to ensure the CCVP facility is always maintained to safety and GMP standards.
• Ensure availability of raw materials, accuracy of inventory, validated facility and equipment.
• Monitor and communicate planned and actual batch deliveries, and operations using metrics.
• Ensure training of staff on safety, equipment, process, SAP, and other activities, as required.
• Design/review production master and executed batch records or other documents (e.g. validation protocols) that meet applicable standards.
• Prepare/review standard operating procedures (SOPs) related to facility, equipment, and processes for the CCVP facility.
• Drive continuous improvement of processes, facilities, and equipment.
• Initiate, investigate and perform corrective actions for manufacturing-related deviations, investigations and corrective and preventative actions for all levels of complexity and scope.
• Initiate change requests.
• Operate pilot-scale bioprocessing and interact fluidly with peers in Manufacturing, and cross-functionally with counterparts on the Quality Control, Quality Assurance, Supply Chain, Facilities and MSAT teams.
• Support technology transfer of new product(s) in parallel with ongoing projects and ensure GMP readiness to manufacture on time.
• Technical champion to the organization within their area(s). Provides formal or informal mentoring across the organization.
• Able to accommodate shiftwork.

LEADERSHIP RESPONSIBILITIES:

• Provides supervision and training to Operations Associates and ensures all operations are performed according to SOPs and health and safety procedures.
• Provide guidance to Operations Associates on proper Good Documentation Practices.
• Assist in the training of employees in aseptic processing and build high performing team.
• Provide technical expertise as a subject matter expert to the project team and execute the project to plan.
• Independently plans, executes, and analyzes complex tasks for multiple projects.
• Identifies gaps in operations, and guides others to develop techniques and procedures to fill those gaps.
• Communicates well across project teams in a leadership role.
• Independently initiates and/or leads collaborations with other business units within the organization or with external stakeholders.