Description

The Arnie Charbonneau Cancer Institute in the Cumming School of Medicine invites applications for a Process Development Specialist. This Full-time Fixed Term position is for approximately 1 year (based on length of grant funding), with the possibility of extension.

The Riddell Centre for Cancer Immunotherapy is seeking a Process Development Specialist to join its Biomanufacturing Program and support the development and clinical translation of novel cell and gene therapies, including gene-edited hematopoietic stem cell (HSC) therapies. The position reports to the Associate Director of Biomanufacturing.

The Process Development Specialist will work across Process Development, Manufacturing, Quality Control, Quality Assurance, research, and regulatory teams to translate research-stage protocols into robust manufacturing processes and analytical control strategies suitable for clinical use. The role requires scientific independence, technical judgement, and organization, with responsibility for managing multiple development activities and project timelines.

The position is primarily laboratory-based and involves work with human cells, biological materials, and gene delivery and gene-editing technologies in accordance with institutional safety, quality, and biosafety requirements.

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

Process Development:

• Design, optimize, characterize, and scale cell culture, cell engineering, and gene-editing manufacturing workflows
• Translate research protocols into robust and reproducible processes suitable for GMP manufacturing
• Define and evaluate critical process parameters, critical quality attributes, and appropriate process controls
• Design and execute studies to understand process performance, variability, and product quality
• Support technology transfer of developed processes into GMP manufacturing

Analytical and QC Assay Development:

• Develop, optimize, and qualify analytical methods and QC assays for product identity, purity, safety, potency, and other critical quality attributes
• Establish assay controls, performance characteristics, acceptance criteria, and standardized workflows
• Contribute to product specifications and analytical control strategies

CMC Documentation and Regulatory Support:

• Maintain complete and traceable experimental records in accordance with QMS requirements
• Author and review protocols, SOPs, technical reports, assay qualification documents, and other controlled documentation
• Summarize process and analytical development data to support CMC, QOS, and Clinical Trial Application documentation

Collaboration and Project Leadership:

• Independently lead assigned development activities and drive work toward defined technical milestones
• Collaborate closely with investigators, Process Development, Manufacturing, QC, QA, and regulatory teams
• Present findings, technical risks, and recommendations to project teams and program leadership
• Participate in project planning, technical troubleshooting, and cross-functional team activities

Qualifications / Requirements:

• MSc or PhD in Cell Biology, Molecular Biology, Immunology, Biomedical Engineering, Biochemistry, or a related field
• Hands-on experience in cell and gene therapy, cell engineering, gene editing, or a related biomanufacturing field
• Strong foundation in aseptic mammalian cell culture, with experience working with human hematopoietic stem cells and/or immune cells considered a strong asset
• Experience in process development, optimization, characterization, or scale-up of cell-based manufacturing processes
• Experience developing and qualifying analytical methods or QC assays
• Demonstrated experience in experimental design, troubleshooting, data analysis, and interpretation
• Ability to independently lead technical projects and drive work toward defined milestones
• Strong scientific writing, communication, and presentation skills
• Proficiency in flow cytometry, including panel design, staining, acquisition, and analysis
• Experience with cell-based functional and potency assays
• Experience with molecular biology and nucleic acid analytical techniques such as PCR, qPCR/ddPCR, cloning, sequencing, or NGS workflows
• Experience with viral and/or non-viral gene delivery technologies, including lentiviral vectors, electroporation, lipid nanoparticles, or virus-like particles, is considered an asset
• Experience contributing to technical or regulatory documentation, including CMC, QOS, or similar regulatory data packages, is considered a strong asset

Application Deadline: September 11, 2026

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 2 .

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