Research Associate – Stem Cell Process Development & GMP Manufacturing

The Faculty of Medicine & Dentistry is one of the world’s top academic health science centres. With 21 departments, multiple research institutes and centres, and a focus on excellence in education, research, and clinical care, the faculty trains outstanding medical and dental professionals and drives global health innovation in collaboration with partners across sectors.

This position has an initial appointment of 12 months.

Location – This role is in-person at North Campus Edmonton.

The Shapiro Stem Cell Diabetes Lab, led by Principal Investigator Dr. James Shapiro, is seeking a highly qualified Senior Research Associate to drive Cell Therapy Process Development and Manufacturing of autologous islets derived from human pluripotent stem cells. This role is pivotal in establishing a core stem cell facility and advancing translational research into clinical cell therapies, with a focus on pancreatic cell development and differentiation.

We are seeking a Researcher who can:

1. Lead bioengineering research on human pluripotent stem cells, optimizing processes for large-scale manufacturing of clinical-grade stem cell and islet products.
2. Develop and implement Standard Operating Procedures (SOPs) for pre-GMP and GMP-compliant cell manufacturing, ensuring adherence to regulatory standards.
3. Independently plan, execute, and analyze complex experiments to produce high-quality, safe, and functional stem cell-derived islet cell products.
4. Collaborate with the Clinical Islet Transplant Program (CITP) to support translational research and clinical trials for novel patient treatments.

Why Join Us?

This role offers the opportunity to contribute to cutting-edge research in stem cell therapy and diabetes treatment, working alongside a world-renowned team at the Alberta Diabetes Institute. You’ll play a key role in translating scientific discoveries into life-changing clinical applications while adhering to the highest standards of quality and safety.

• GMP Process Development & Technology Transfer: Lead high-level research design, optimize manufacturing protocols, manage technology transfer and drive protocol implementation.
• Advanced Research & Laboratory Operations: Manage laboratory facilities, execute cutting-edge experiments, drive automation innovation, data analysis.
• Quality Control & Regulatory Compliance: Execute quality testing, manage regulatory documentation, ensure data integrity, SOP management.
• Scholarly Dissemination and Communication: Publish research findings, present scientific findings at lab meetings, national and international scientific conferences, collaborate on reporting with the PI and collaborators.
• Financial and Grant Management to support the CITP Operations Director: Manage budgets, secure funding, manage space and equipment grants.
• Personnel Leadership and Supervision: Supports the CITP Operations director with supervision of lab staff by providing daily oversight of research personnel.
• Supports the Operations Director with recruitment activities to hire postdoctoral fellows, technicians and graduate students, provide training and mentorship to research personnel, public relations activities along side the PI to promote the labs work.

• PhD in Islet Biology, Stem Cell Regenerative Medicine, or a related discipline.
• Required Experience: A minimum of 5 years of postdoctoral experience plus 2 years of
  previous research associate experience.
• Research Focus: Extensive background in pluripotent stem cell biology, somatic cell
  reprogramming, pancreatic development, islet biology, physiology, and/or transplantation with a proven high-quality publication record.
• Stem Cell Expertise: Extensive hands-on experience with Human ESC/iPSC culture and
  somatic cell reprogramming.
• Differentiation: Expert knowledge in pancreatic cell differentiation and the generation of islet cells in 2D and 3D culture systems (planar, suspension bags, and 3D suspension bioreactor-based cell culture).
• Manufacturing: Knowledge of gene-edited cell manufacturing and cell processing for clinical grades.
• Core Assays: Proficiency in immunohistochemistry, advanced molecular microscopy, real-time gene expression (PCR/Gene array), and ELISA assays.
• Advanced Genomics: Skills in single-cell RNA sequencing (sc-RNA seq) data
  generation/analysis, spatial transcriptomics, and karyotyping.
• Gene Editing: Experience with CRISPR/Cas9 technology (vector production and gene editing).
• Surgical Skills: Hands-on experience with animal surgeries, specifically islet transplantation.
• Procedures: Proficiency in dosing, injections, IPGTTs (Intraperitoneal Glucose Tolerance Tests), as well as blood and tissue collection.
• Flow Cytometry: Expert knowledge and skills in multi-parameter flow cytometry.
• Research Design: High-level skills in experimental design, data analysis, and troubleshooting.
• Regulatory Knowledge: Demonstrated knowledge of GLP (Good Laboratory Practice) and GMP
  (Good Manufacturing Practice) procedures, including reviewing and approving GMP SOPs.
• Communication: Strong verbal and written science communication skills for manuscript and abstract writing, presentations, and drafting/submitting research funding applications (including CFI).
• Management: Experience in designing and developing core facilities, along with supervisory and project management duties.

Application Instructions

Click “Apply Now” to submit your curriculum vitae and list of publications.

This position offers comprehensive benefits package with an annual salary range of $80,772 to $111,086.

The terms and conditions of this appointment are governed by Schedule E of the Collective Agreement between the Board of Governors of the University of Alberta and the Association of the Academic Staff of the University of Alberta.