Job Description

Position

Summary:

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As an Operations Associate I at CCRM, the role will be part of a diverse bioengineering team focused on designing and implementing Good Manufacturing Practices (GMP) production projects for the Centre for Cell and Vector Production, CCRM's GMP facility. 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.

Responsibilities:

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Extracts information from equipment manuals and other source documents, and writes easy-to-understand, simple, user-friendly standard operating procedures (SOPs) that describe the equipment, key operating parameters, maintenance and cleaning procedures. Cleans, maintains and documents equipment in the clean room for use. Performs process validation, process optimization and process development as required. Assists in the design and execution of the production batch records or other high-quality documents (i.e., HVAC validation) that meet applicable standards and are appropriate for the intended audience. Ensures that the controlled Grade A and B manufacturing areas are clean and remain in a state of control. Supports the development and execution of appropriate safety, training, gowning, material movement, cleaning and scheduling. Completes batch records (BRs), logbooks, forms, etc., under GMP, and documents everything, in detail, through the use of SOPs and BRs for the process and manufacturing steps. Writes and updates SOPs and master batch records. Adheres to GMP and good documentation practices (GDP). Operates pilot-scale bioprocessing and interacts fluidly with peers and supervisors in Operations, and cross-functionally with Quality Control, Quality Assurance and Logistical counterparts. Collaborates with the Process Development and Manufacturing Sciences and Technology groups to transfer new projects into GMP. Implements a program to monitor and control operations from an employee safety perspective. Other process-related tasks that may arise.

Qualifications:

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BSc in biological or life sciences, biotechnology or microbiology, or equivalent industry experience. 1+ years of experience in biopharmaceutical-based GMP manufacturing operations/cell therapy/human cell cultivation. Hands-on experience working in a GMP environment is preferred Strong English written and verbal communication skills. Proven track record of writing GMP documents (i.e., SOPs, validation procedures).

Desired

Characteristics:

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Proven track record of working in Grade A and B controlled environments performing aseptic processing. Proven track record of cellular and tissue culture experience, immune cell isolation and expansion technique. Technical understanding of cell culture processes. Understanding of Health Canada/U.S. Food and Drug Administration GMP regulations and quality assurance principles. Able to deliver high-quality product and other deliverables, paying attention to details. Able to quickly grasp complex technical concepts and make them easily understandable in text and pictures. Familiarity with health and safety regulations. Excellent communication and interpersonal skills with assertive and responsible attitude, and demonstrates accountability. Strong working knowledge of Microsoft Office. * Basic familiarity with enterprise quality management software.