Senior Scientist, Process Development

Notch Therapeutics

About Notch (www.notchtx.com)

Notch Therapeutics is an immune cell therapy company developing universally compatible, genetically enhanced, allogeneic T cell therapies from renewable stem cell sources for the treatment of high-impact diseases, with an initial focus on cancer. Recently funded and rapidly growing, Notch is looking for scientifically curious and intrinsically motivated individuals who thrive in a cross-disciplinary and collaborative environment.  

Role Summary

As a Senior 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 reagents that drive differentiation of induced pluripotent stem cell (iPSC) to functional T cells. You will be responsible for supervising the process development team within Engineering, in translating research protocols into processes suitable for cell therapy ancillary reagent 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.

Key Responsibilities

  • Manage analytical and process engineering teams to translate research scale bead-based ancillary reagent synthesis methods into a closed, aseptic process at a relevant scale for manufacturing.
  • 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.
  • Responsible for coordinating manufacturing partnerships and oversee the 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
  • Work with research team to conceive, plan and execute projects that enhance and extend intellectual property by elucidating mechanism of action for key discoveries and extending the scope of IP coverage
  • 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

Qualifications and Experience

  • Degree in chemical engineering, biomedical engineering, cell biology, or a related discipline with at least 10 years of relevant academic and industrial experience.
  • Experience managing an industrial research or product development team is required, with preference for experience in therapeutic program 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.
  • Experience in aseptic process development with understanding of bioprocess engineering concepts.
  • Hands-on experience of advanced statistical experiment design (using Minitab, JMP etc.) and automated data analysis using programming tools (Python, R etc.) is preferred.
  • Ability to independently propose, design, execute and report on research and development projects.
  • Excellent written and oral communication skills.

To apply for this position please use the following link: Notch Therapeutics – Notch Therapeutics (notchtx.com)