Cell Manufacturing Lead, Arnie Charbonneau Cancer Institute

Description

The Arnie Charbonneau Cancer Institute in the Cumming School of Medicine invites applications for a Cell Manufacturing Lead. This Full-time Fixed Term position is for approximately 12 months (based on length of grant funding), with the possibility of extension.

This position reports to the Associate Director of Biomanufacturing at the Riddell Centre.

The mission of the Riddell Centre is to reduce the burden of cancer and improve patient survival through the rapid development and implementation of safe and effective immunotherapies. The Biomanufacturing Program supports this mission by producing high-quality cell therapeutics and supportive reagents for preclinical research, product development, and clinical translation.

The successful candidate will be responsible for overseeing the Centre¿s cell therapy manufacturing, working closely with the leadership team and key technical and quality staff across process development, quality control, regulatory affairs, and quality assurance. This role also involves direct collaboration with external partners such as Alberta Precision Laboratories (APL), Alberta Health Services (AHS), and members of the broader cell therapy community.

Initially, the Cell Manufacturing Lead will help coordinate manufacturing activities at the FACT-accredited Cell Therapy Laboratory (CTL), working closely with their team to ensure early manufacturing needs are met. In parallel, they will play a critical role in commissioning and operationalizing a new cGMP cell therapy manufacturing facility within the Riddell Centre, where they will eventually oversee all manufacturing operations.

Summary of Key Responsibilities (job functions include but are not limited to):

Cell Manufacturing Leadership

• Work collaboratively with CTL to manufacture CAR T cells for ongoing trials
• Lead the development, commissioning, and operation of the new cGMP cell therapy manufacturing lab
• Oversee all manufacturing activities for CAR T and other cell-based therapies, ensuring strict cGMP compliance
• Collaborate with process development teams to implement robust manufacturing protocols and technology transfers
• Develop and oversee training programs to ensure staff maintain consistent competency across manufacturing activities

Process Development & Optimization

• Collaborate with process development teams to optimize cell culture processes, including isolation, activation, transduction, expansion, and cryopreservation
• Support technology transfer from process development to GMP production, ensuring seamless scale-up and process validation
• Identify and implement continuous process improvements to enhance efficiency, quality, and cost-effectiveness

Collaboration & Communication

• Collaborate closely with internal teams and external partners (CTL, APL, AHS, and others) to ensure smooth and compliant manufacturing operations
• Act as the primary contact for manufacturing-related audits, inspections, and external inquiries

Regulatory Compliance

• Ensure all manufacturing activities and documentation adhere to cGMP, GDP, and GLP standards, aligned with Health Canada, FDA, and ICH guidelines
• Lead the preparation, review, and ongoing improvement of manufacturing documents (SOPs, batch records, training materials)

Continuous Improvement & Problem Solving

• Identify and resolve manufacturing issues quickly, implementing corrective and preventive actions (CAPAs) as needed
• Stay current with evolving industry standards by attending relevant conferences, workshops, and training

Safety & Risk Management

• Ensure all manufacturing activities are conducted safely, following established protocols to minimize risks
• Perform regular risk assessments and implement necessary mitigation strategies

Qualifications / Requirements:

• Ph.D. in Cell Biology, Biotechnology, Immunology, or a related field
• Extensive experience in cell therapy manufacturing, including T cell culture and genetic modification (e.g., transduction, electroporation)
• Experience managing operations within a GMP-regulated environment, including process development, technology transfer, and production scale-up
• Strong self-directed learning skills with the ability to efficiently acquire new techniques and adapt to emerging technologies and methodologies
• Expertise in aseptic cell culture, cell isolation, expansion, and cryopreservation
• Proficiency with manufacturing platforms such as the CliniMACS Prodigy or similar systems
• Familiarity with analytical methods for in-process and final product testing (e.g., flow cytometry, ELISA, PCR)
• Experience with electronic batch records and Quality Management Systems
• Proven leadership experience, including training and mentoring technical staff
• Strong organizational and project management skills to balance multiple priorities under tight deadlines
• Advanced problem-solving skills to navigate complex issues within a dynamic regulatory landscape
• Knowledge of GxP regulations (GDP, GLP, GMP), with familiarity with relevant Health Canada, FDA, and ICH guidelines

Application Deadline:  March 27, 2025

We would like to thank all applicants in advance for submitting their resumes. Please note, only those candidates chosen to continue on through the selection process will be contacted.

This position is part of the AUPE bargaining unit, and falls under the Technical Job Family, Phase 3.

For a listing of all management and staff opportunities at the University of Calgary, view our Management and Staff Careers website. 

About the University of Calgary

UCalgary is Canada's entrepreneurial university, located in Canada's most enterprising city. It is a top research university and one of the highest-ranked universities of its age. Founded in 1966, its 36,000 students experience an innovative learning environment, made rich by research, hands-on experiences and entrepreneurial thinking. It is Canada's leader in the creation of start-ups. Start something today at the University of Calgary. For more information, visit ucalgary.ca.

The University of Calgary has launched an institution-wide Indigenous Strategy committing to creating a rich, vibrant, and culturally competent campus that welcomes and supports Indigenous Peoples, encourages Indigenous community partnerships, is inclusive of Indigenous perspectives in all that we do.

As an equitable and inclusive employer, the University of Calgary recognizes that a diverse staff/faculty benefits and enriches the work, learning and research experiences of the entire campus and greater community. We are committed to removing barriers that have been historically encountered by some people in our society. We strive to recruit individuals who will further enhance our diversity and will support their academic and professional success while they are here. In particular, we encourage members of the designated groups (women, Indigenous peoples, persons with disabilities, members of visible/racialized minorities, and diverse sexual orientation and gender identities) to apply. To ensure a fair and equitable assessment, we offer accommodation at any stage during the recruitment process to applicants with disabilities. Questions regarding [diversity] EDI at UCalgary can be sent to the Office of Institutional Commitments ([email protected]) and requests for accommodations can be sent to Human Resources ([email protected]).

Do you have most but not all the qualifications? Research show that women, racialized and visible minorities, and persons with disabilities are less likely to apply for jobs unless they meet every single qualification. At UCalgary we are committed to achieving equitable, diverse, inclusive and accessible employment practices and workplaces and encourage you to apply if you believe you are right for this role. 

We encourage all qualified applicants to apply, however preference will be given to Canadian citizens and permanent residents of Canada.