LOCATION: Waltham, MA
TScan Therapeutics is a well-funded startup biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are seeking a Principal Scientist / Associate Director in Cell Therapy Process Development to support innovative efforts in building clinical manufacturing processes for our novel TCR-engineered T cell therapy products. This role will reside within the Technical Development & Manufacturing group and will work closely with key members of the CMC, Preclinical, and Discovery teams. Key activities will include leading the development of next generation cellular manufacturing processes, process scale-up and optimization, IND-enabling activities, and the tech transfer to clinical manufacturing, amongst others. A team player with a sense of urgency will thrive in this role.
- Responsible for the strategic planning and execution of cellular process development activities related to the generation of a robust cellular engineering process to support IND enabling studies and GMP manufacturing
- Act as a strong scientific leader within the Process & Analytical Development team and represent the group to both internal stakeholders and external vendors
- Management of technical staff, review and interpretation of collective data sets, and cross-functional coordination of activities with analytical development, manufacturing, pre-clinical sciences, and supply chain, amongst others.
- Act as primary SME for all internal and external process development and process instrumentation engineering activities including, but not limited to, target cell isolation platforms, automated cell washing, electroporation systems, controlled rate freezing systems, culture expansion, and cryopreservation systems
- 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 & 8-10 years of experience OR MS & 10-12 years of experience; degree emphasis in biomedical/chemical engineering, cell biology, biological sciences, immunology or related field is preferred
- Ideal candidate will have a background in cellular bioprocessing and exposure to the cGMPs and ICH guidelines related to the manufacture of human cell and gene therapies
- Experience with DoE-based experimental design and execution, design of custom aseptic connections / closed fluidics paths, as well as common in-process cellular analytics such as live/dead assays, cell enumeration, and flow cytometry are highly desired
- Experience developing manufacturing strategies for human primary T cell products is preferred, with focus on cell isolation and culture expansion-related manufacturing challenges
- Scientific creativity, critical thinking, ability to innovate, and be a steadfast analytical problem solver
- Team player energized by a fast-paced, lean and agile environment who can foster productive relationships with internal colleagues
- Excellent communication skills (both written and oral)
- Experience drafting manufacturing documentation and supporting documentation for regulatory filings is strongly desired
TScan 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.
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 is an environment that supports innovation, camaraderie and professionalism. We are driven, passionate, fun, flexible and team oriented. Sound like you? Apply today.