Notch Therapeutics Inc..
As a Scientist, Process Development at Notch Therapeutics, you will be part of a diverse team focused on advancing iPSC-derived T-cell therapeutics from discovery-stage through scale-up and clinical manufacturing. You will provide deep technical knowledge and practical expertise in development of Notch’s Engineered Thymic Niche and other critical ancillary materials that drive differentiation of induced pluripotent stem cell (iPSC) to functional T cells. You will be responsible for developing appropriate manufacturing processes for custom cell therapy raw materials at suitable scale and assisting with transfer to manufacturing. In this role you will be responsible for task definition, planning,
execution and reporting of internal and partner-facing projects. In addition, you will work closely with the engineering research team for ideation, planning and development of novel solutions for Notch’s T cell production process. You will be a leader in bringing new and innovative products, technologies, and processes to market to enable life-saving advances in cell therapy.
About Notch (www.notchtx.com)
Notch Therapeutics is a cell therapy company that has unlocked the ability to produce T cells and other cells from any source of stem cells. At the core of the Notch technology is the Engineered Thymic Niche (ETN) platform, which enables precision control of cell fate during the differentiation and expansion of stem cells. The ETN is the first technology that can reliably generate T-cells from iPSC-derived progenitor cells using fully defined, non-xenogenic reagents at industrial scale. By leveraging the ETN platform, Notch is positioned to design and deliver the next generation of T cell therapeutics that are specifically engineered to address the underlying biology of complex disease systems. The technology was invented in the laboratories of Juan-Carlos Zúñiga-Pflücker, Ph.D. at Sunnybrook Research Institute and Peter Zandstra, Ph.D., FRSC at the University of Toronto. Notch was founded by these two institutions, in conjunction with MaRS Innovation (now Toronto Innovation Acceleration Partners) and the Centre for Commercialization of Regenerative Medicine (CCRM) in Toronto.
Notch is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization. Applicants must be legally eligible to work in hired location (Canada or USA). Notch is committed to accessibility, diversity and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.
- Translate research scale bead-based reagent synthesis methods into a closed, aseptic process at a relevant scale for manufacturing.
- Work with the Research and Development group to confirm product performance and consistency are maintained at each stage of process development.
- Work with Quality and Regulatory groups to ensure development activities, process equipment, process characterization and documentation are consistent with needs of future regulated manufacturing process.
- Work with manufacturing partners to ensure successful technology transfer of optimized processes.
- Apply engineering principles to systematically increase process robustness and identify and characterize critical quality attributes.
- Design and implement manufacturing solutions to ensure adequate supply of materials to support research and development efforts.
- Collaborate closely with the research team to ensure alignment of design improvements and appropriate analytical characterization
- Collaborate with the computational biology and engineering teams to generate data for modeling. Use model predictions to drive hypothesis generation and testing.
- Define milestones and create project timelines and budgets.
- Drive effective communication across the organization.
- Demonstrate continuous integrity, credibility, and positivity and motivate others to do the same.
Other responsibilities as required
Role Requirements and Qualifications
- Degree in chemical engineering, biomedical engineering, or a related discipline with at least 5 years of relevant academic and industrial experience.
- Experience in aseptic process development with understanding of bioprocess engineering concepts.
- Experience executing on industrial process development projects is required, with preference for experience in cell therapy process development.
- Scientific background and understanding of cell and gene therapy, including upstream and downstream cell processing steps, scale-up, technology transfer, GMP manufacturing and product characterization is preferred.
- Hands-on experience of advanced statistical experiment design (using Minitab, JMP etc.) and automated data analysis using programming tools (Python, R etc.) is preferred.
Desired Characteristics and Demonstrated Skills
- Ability to independently propose, design, execute and report on research and development projects.
- Excellent written and oral communication skills.
- Demonstrated ability and keen interest in modelling Notch’s Core Values: Collaborative, Motivated, Ingenious