Process Development, Scale-up and GMP Manufacture of Novel Cell & Gene Therapies- ON-501

Project type: Research
Desired discipline(s): Engineering - biomedical, Engineering, Biochemistry / Molecular biology, Life Sciences, Genetics
Company: Centre for Commercialization of Regenerative Medicine (CCRM)
Project Length: Longer than 1 year
Preferred start date: 01/01/2022
Language requirement: English
Location(s): Toronto, ON, Canada; Canada; Canada
No. of positions: 20 to 30 positions
Desired education level: CollegeUndergraduate/BachelorMaster'sPhDPostdoctoral fellow
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About the company: 

The Centre for Commercialization of Regenerative Medicine (CCRM) was created to maximize Canada’s research leadership in Regenerative Medicine (RM), an area of discovery that promises to revolutionize medicine with cures for some of the world’s most debilitating diseases. CCRM’s model advances new RM inventions and discoveries in a collaborative manner working with researchers in both academia and industry, throughout Canada and beyond.

CCRM operates two core research facilities in the MaRS Centre in Toronto. The Centre for Advanced Therapeutic Cell Technologies (CATCT) was established through a partnership with the Government of Canada and GE Healthcare (now Cytiva). This facility provides the essential infrastructure and expertise to bridge the gap between pre-clinical research and the clinic ready manufacturing of cell and gene therapies. The Centre for Cell and Vector Production (CCVP), established in partnership with University Health Network (UHN), is an accredited facility that provides clinical grade Good Manufacturing Practices (GMP) products for Phase I and II in-human clinical trials, along with an affiliated analytics team to qualify novel therapies for use in patients.

CCRM is also affiliated with OmniaBio – a commercial GMP manufacturing facility being developed at McMaster Innovation Park.

Describe the project.: 

Research programs at CCRM are based on sixcore themes. Novel research projects can be defined within any of the following core themes to best align with candidates' skills and interests.

  1. iPSC and Gene Editing – iPSC (induced pluripotent stem cells) and gene editing research focuses on reprogramming a variety of cell lines for specific functions. 
  2. Media and Cell Development – Research in media formulations focuses on optimizing conditions for cell development and growth. This research is supported by capabiliites in liquid handling robotics and mass spectrometry analytics.  The goal will be media, cell products or cell products that support analytics.
  3. Non-Viral Genetic Transfer – Research in genetic, non-viral transfer for cells focuses on systems that can deliver novel genetic therapies to host cells via a variety of techniques. 
  4. Viral Vector Development – Research using viruses as a vector to deliver novel genetic materials to host cells has included several types of viruses including lenti-viral (LV), adeno-associated viral (AAV) development and others.
  5. T-Cell and CAR-T Development – Research on T-Cells and CAR-T (chimeric antigen receptor T-cells) focuses on reprogramming patients' immune cells to attack a foreign pathogen.
  6. Analytics Develpment – Research on characterization analytics focuses on the testing that will be required for novel therapies to ensure quality control and patient safety.  A key focus will be for potency assays.

Additional technology development platforms could include Bioprinter, Biomaterials and Beads for use in various cell therapy applications.  CCRM's goal is to maintain best-in-class capabilities in growing, processing and analyzing cells. 

Training in GMP manufacture is an additional opportunity for internship projects.

Required expertise/skills: 

  • A variety of science and engineering backgrounds will be considered. The applications are broad, with different and challenging problems to solve. 
  • Advanced degree candidates that are interested in an “applied academic” framework to advance their knowledge and understanding of industry are encouraged to apply.  Candidates will need to have excellent technical and interpersonal communication skills, both written and verbal. Perhaps more important are the soft-skill capabilities to work with a world-class team, supporting the team leaders who have significant experience in cell therapy applications. 
  • College trained and undergraduate students with previous experience in a laboratory setting, and with strong technical skills, are also encouraged to apply. Candidates will be exposed to a highly regulated, high pressure work environment. Strong team work and interpersonal skills are required to succeed.
  • Applications to CCRM may be particularly interesting for those who have entrepreneurial aspirations in their future.