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 Cell Manufacturing Lead will be responsible for the production of clinical-grade cell therapies in support of early-phase clinical trials, including CAR T cell manufacturing. In the near term, this role will coordinate manufacturing activities in collaboration with the FACT-accredited Cell Therapy Lab (CTL) within Alberta Precision Laboratories (APL). In parallel, the successful candidate will lead the commissioning and operational launch of a new cGMP cell therapy facility at the Riddell Centre¿establishing scalable, long-term manufacturing capabilities.
This position operates at the interface of research and clinical application, with close collaboration across internal teams in process development, quality control, quality assurance, and regulatory affairs, as well as external partners such as APL and Alberta Health Services (AHS). It is ideally suited to a candidate with both technical expertise and leadership experience, ready to help shape and deliver a high-impact cell therapy manufacturing program.
Summary of Key Responsibilities (job functions include but are not limited to):
Cell Manufacturing Leadership:
- Lead GMP-compliant manufacturing of CAR T and other cell-based therapies
- Coordinate with CTL to ensure uninterrupted production for ongoing trials
- Guide the design, commissioning, and operational readiness of the Centre¿s cGMP manufacturing lab
- Develop training programs and ensure staff maintain consistent technical competency and compliance
Process Development & Optimization
- Collaborate with process development teams to implement robust and scalable manufacturing protocols
- Support tech transfer and scale-up activities from development to clinical production
- Identify and implement process optimizations to improve quality, efficiency, and cost-effectiveness
Collaboration & Communication
- Maintain strong relationships with internal teams and external collaborators to support seamless production
- Serve as the point of contact for audits, inspections, and manufacturing-related external communications
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
- Resolve manufacturing issues promptly, using CAPAs and root cause analysis when needed
- Remain informed of evolving regulatory and technical standards through ongoing training and conference participation
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)
- Proven leadership in GMP-regulated environments, including oversight of technology transfer and clinical-scale production
- Strong self-directed learning skills with the ability to efficiently acquire new techniques and adapt to emerging technologies and methodologies
- Deep expertise in aseptic cell culture, including cell isolation, expansion, and cryopreservation
- Experience with closed-system platforms such as CliniMACS Prodigy or similar automated systems
- Proficiency in in-process and final product testing methods (e.g., flow cytometry, ELISA, PCR)
- Familiarity with electronic batch records (EBRs) and Quality Management Systems (QMS)
- Demonstrated experience leading and mentoring technical staff in a regulated environment
- Strong organizational and project management skills to manage competing priorities under tight timelines
- Effective problem-solving and decision-making in complex, dynamic settings
- In-depth understanding of GxP regulations (GMP, GLP, GDP), with working knowledge of Health Canada, FDA, and ICH guidelines
Application Deadline: May 13, 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 (equity@ucalgary.ca) and requests for accommodations can be sent to Human Resources (hrhire@ucalgary.ca).
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.
