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 seeking a Research Associate / Sr. Research Associate / Principal Research Associate in Cellular Process Development to support innovative efforts in building clinical manufacturing processes for the company’s novel TCR-engineered T cell therapy products. This newly created role will reside within the Process & Analytical Development Team and will work closely with other members in technical development & manufacturing as well as key members of the pre-clinical and discovery teams. Key activities will include the development of cellular manufacturing processes, process scale-up and optimization, IND-enabling activities, and the tech transfer to clinical manufacturing, amongst others.
The ideal candidate will (i) have a background in cellular bioprocessing and exposure to 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.
The candidate should have exposure to cell processing instrumentation including target cell isolation platforms, automated cell washing, electroporation systems, controlled rate freezing systems, amongst others, and have experience with culture expansion and cryopreservation systems. 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. 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 execution, interpretation, and presentation of results related to experimental studies
- Support development and optimization of cell manufacturing unit operations to support IND enabling studies and clinical manufacturing
- 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 (standard operating procedures, master batch records), to support tech transfer
- Document all experimental work in the electronic lab notebook (ELN) in a timely manner
- Generate and maintain cell inventories
- Collaborate with internal teams to ensure adequate cells are isolated and cryopreserved to support program research and development needs
- Work with Analytical Development to generate and analyze data to develop understanding of key quality attributes of cell-based drug products to guide safe and effective clinical testing and process control strategies
- Collaborate closely with the manufacturing team or external DMO partner(s) as needed to tech transfer the developed process into GMP manufacturing and act as SME during training / process shake-down runs
- BS with 3+ years or of relevant industry experience; degree emphasis in immunology, cell biology, biological sciences, biomedical/chemical engineering or related field is preferred
- Scientific creativity, critical thinking, ability to innovate, and analytical problem solving
- Excellent communication skills (both written and oral)
- Strong organizational skills with the ability to prioritize assignments in order to meet program goals in a fast-paced environment
- Attention to detail and the ability work independently, within a multi-disciplinary team, as well as with external partners and vendors, if needed
- Experience developing manufacturing strategies for human primary T cell products is preferred, with focus on cell isolation and culture expansion-related manufacturing challenges
- Experience with aseptic technique, preferably including isolating, culturing and freezing cells using automated equipment and closed processes
- Experience drafting manufacturing documentation and supporting documentation for regulatory filings is strongly desired
- Understanding of FDA, EMA, and ICH regulations, industry standards and quality control principles for GMP operations is preferred
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.