LOCATION: Waltham, MA
TScan Therapeutics is a startup biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Senior/Principal Scientist in Cellular Process Development to drive innovative efforts in building clinical manufacturing processes for the company’s novel non-viral engineered TCR-T cell therapy products. This newly created role will reside within the Technical Development & Manufacturing Team and will report to the Senior Director of Process Development. Key activities will include the bench-scale feasibility studies, process scale-up and optimization, IND-enabling activities, and the tech transfer to clinical manufacturing, amongst others.
The ideal candidate will (i) have a strong background in cellular bioprocessing and a firm understanding of the cGMPs and ICH guidelines related to the manufacture of human cell and gene therapies; (ii) be a steadfast problem solver who is energized by a fast-paced, lean, and agile environment; and (iii) be a team player who can foster productive relationships with internal colleagues and with external partners.
The candidate should be well-versed in a variety of state-of-the-art cell processing instrumentation including processing of apheresis products, target cell isolation platforms, automated cell washing, controlled rate freezing systems, cell expansion and cryopreservation. Experience with non-viral delivery modalities such as electroporation, mechanoporation, microfluidics, and a background in novel instrument development are highly desired attributes. A team player with a sense of urgency will thrive in this role.
T-Scan Therapeutics was founded in 2018 by a small group of scientists led by Dr. Stephen Elledge (Harvard Medical School/HHMI). TScan is discovering and developing novel TCR-engineered T cell therapies for the treatment of cancer. TScan’s discovery platform is centered around a breakthrough technology that enables the rapid, comprehensive, and genome-wide identification of the peptide antigen targets of T cell receptors. This technology greatly enhances our ability to understand the specific antigens that drive important disease processes, including tumor cell recognition by the immune system, self-reactivity in autoimmune disorders, and acquired immunity in infectious disease. TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development.
- Responsible for the design, execution, and interpretation of experimental studies
- Develop, optimize and scale up a robust cell manufacturing process to support IND enabling studies and GMP manufacturing
- Act as primary SME for all process development and process instrumentation engineering activities
- Author and review of technical documentation to support early-stage activities (development reports and supporting documentation for regulatory filings) as well as draft manufacturing documentation to support tech transfer
- Collaborate closely with manufacturing to tech transfer the developed process to a GMP facility and act as SME during training/process shake-down runs
- PhD with 5+ years of relevant industry experience. Degree emphasis in biological sciences, biomedical/chemical engineering or related field is preferred
- Background developing manufacturing strategies for human primary T cell products is preferred, with focus on the building of functionally closed processes
- Experience in the development/engineering of novel cell processing and/or microfluidic-based instrumentation is highly desired
- Scientific creativity, critical thinking, ability to innovate, and analytical problem solving
- Excellent communication skills (both written and oral)
- Experience drafting manufacturing documentation and supporting documentation for regulatory filings
Do YOU have the anatomy of a TScanner?
Our talented, compassionate, and intelligent team is what makes TScan a great place to work. Our brand-new offices with approximately 40,000 square feet of premium lab and office space as well as 4000 square feet of GMP manufacturing space provides an environment that supports innovation, camaraderie, and professionalism. We are driven, passionate, fun, flexible and team oriented. Sound like you? Apply today.