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 Scientist / Sr. Scientist in Cellular Analytical Development lead efforts in developing test methods for the company’s novel TCR-engineered T cell therapy products. This newly created role will reside within the Technical Development & Manufacturing Team and will report to the Senior Director of Cell Process Development. Key activities will include the development of analytical methods to support cellular product process development, process scale-up and optimization, IND-enabling activities, and the tech transfer of in-process, release, and stability-indicating assay methods to QC, amongst others.
The ideal candidate will (i) have a strong background in cellular analytics and a firm understanding of the cGMPs and ICH guidelines related to the manufacture and testing of human cell and gene therapy products; (ii) be a steadfast problem solver who will thrive in 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 cell-based, molecular, and analyte-based testing including, but not limited to, live/dead assays, cell enumeration, flow cytometry, fluorescence microscopy, fluorimetry, ddPCR / qPCR, and ELISA. Experience with DoE-based experimental design and execution, interpretation of next-generation sequencing data, LC-MS, UPLC are desired. Experience with high-throughput protein / analyte analysis systems are a plus.
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 analytical readouts on TCR-engineered T cell processes and products
- Be a focal point for analytical best practices, suitable for GMP testing, within the organization and introduce these concepts to a research-focused startup
- Develop, optimize and qualify test methods to support IND enabling studies, GMP manufacturing, release and stability testing of T-Scan’s cellular drug products.
- Integrate with the process development function to implement process improvements based on analytical output
- Act as primary SME for tech transfer for all optimized / qualified methods to QC and assist quality in developing testing strategies and validation efforts
- Author and review of technical documentation to support early stage activities (development reports and supporting documentation for regulatory filings) as well as draft QC documentation to support tech transfer
- PhD with 3+ years of relevant industry experience. Degree emphasis in cell biology, immunology, biological sciences, biomedical/chemical engineering or related field is preferred.
- Experience developing test strategies for cell-based therapies is preferred, with focus on process characterization, immunophenotyping, and cell-based potency and toxicity assays.
- Scientific creativity, critical thinking, ability to innovate, and analytical problem solving.
- Excellent communication skills (both written and oral) is critical.
- Experience drafting SOPs and testing documentation as well as supporting documentation for regulatory filings is strongly desired.
- Experience in the development and implementation of phase appropriate and novel approaches to potency assays is desirable.
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 over 10,000 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.
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Scientist / Senior Scientist, Analytical Development