Operations Coordinator

3 weeks ago

Toronto ON, Canada CCRM Full time

About CCRM: CCRM, based in Toronto, Canada, is a unique not-for-profit organization 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 problems 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.

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. Ensures that all daily and weekly production schedules are met.
Ensures daily presence on shop floor and conducts routine walk-throughs to ensure the CCVP facility is always maintained to safety and GMP standards.
Ensures availability of raw materials, accuracy of inventory, validated facility and equipment.
Ensures training of staff on safety, equipment, process, SAP, and other activities, as required.
Designs/reviews production master and executed batch records or other documents (e.g. validation protocols) that meet applicable standards.
Prepares/reviews standard operating procedures (SOPs) related to facility, equipment, and processes for the CCVP facility.
Drives continuous improvement of processes, facilities, and equipment.
Initiates, investigates and performs corrective actions for manufacturing-related deviations, investigations and corrective and preventative actions for all levels of complexity and scope.
Operates 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.
Supports 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). Able to accommodate shiftwork.

Provides supervision and training to Operations Associates and ensures all operations are performed according to SOPs and health and safety procedures.
Assists in the training of employees in aseptic processing and build high performing team.
Provides 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.

Bachelor’s degree in science (biological or life sciences, biotechnology or microbiology), master’s degree is preferred.
~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.Food & Drug Administration (FDA) GMP regulations and quality assurance principles.
~ Experience with electronic quality management systems.
~ Strong English written and verbal communication skills.
~ Strong working knowledge of Microsoft Office programs.
~ Proven track record of writing GMP documents (i.e., Experience with production planning in using enterprise resource planning software.
Knowledge of contract development manufacturing organization businesses.
An applicant’s compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity.

CCRM is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position.

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