Co/Op Term: 12-16 Months

Position Summary:
In the Operations Co-op Placement role at CCRM, you will be part of a diverse bioengineering team focused on designing and implementing Good Manufacturing Practices (GMP) production projects for CCRM’s GMP facility – the Centre for Cell and Vector Production (CCVP). You will provide technical expertise and will work with the team to define and execute project tasks. You will support the team’s operations as it brings new and innovative products to market to enable life-saving advances in cell and gene therapy and regenerative medicine.

Responsibilities: 

• 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 for use in the clean room.
• Performs process validation, process optimization and process development, as required.
• Assists in the design/execution of the production batch records or other high-quality protocols. 
• Supports the development and execution of appropriate safety, training, gowning, material movement, cleaning and scheduling.
• Completes logbooks, forms, etc., under GMP, and documents processes and manufacturing steps in detail in SOPs and batch records.
• Writes and updates SOPs and batch records.
• Adheres to GMP and good documentation practices (GDP).
• Operates pilot-scale bioprocessing equipment.
• Interacts fluidly with peers and supervisors on the Manufacturing team, and cross-functionally with counterparts on the Quality Control, Quality Assurance and Logistical teams.
• Collaborates with the Process Development and Manufacturing Sciences and Technology groups to transfer new projects into GMP.
• Supports the implementation of a program to monitor and control operations from an employee safety perspective.
• Other process-related tasks that may arise.

Qualifications:

• Studying towards a BSc in biological or life sciences, biotechnology, microbiology, or equivalent.
• Hands-on experience working in a GMP environment or laboratory is preferred.
• Strong English written and verbal communication skills.

Desired Characteristics:

• Proven track record of performing aseptic processing.
• Proven track record of cellular and tissue culture experience, immune cell isolation and expansion technique.
• Technical understanding of cell culture processes.
• Able to deliver high-quality products and other deliverables, paying attention to details.
• Able to quickly grasp complex technical concepts and make them easily understandable in text and images.
• Familiar with Environmental Health and Safety regulations.
• Excellent communication and interpersonal skills with an assertive, responsible and accountable attitude.
• Strong working knowledge of Microsoft Office applications (for example, Word and Excel).
• Basic familiarity with enterprise quality management software.

This position may be fully or partially funded by Biotalent Canada. In order to be eligible for funding under Biotalent Canada the applicant must be a Canadian citizen, permanent resident, or a person to whom refugee protection has been conferred and such are legally entitled to work in Canada in accordance with relevant provincial or territorial legislation and regulations. As such, only applicants that meet the above criteria will be eligible for this opportunity.

CCRM is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.

Applicants must be legally eligible to work in Canada.

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. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.