Scientist/Sr. Scientist, Analytical Development (SC06-7)

Location

Waltham, MA | United States

Job description

POSITION SUMMARY:

TScan Therapeutics is a clinical-stage 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 Analytical Development to join efforts in developing test methods for the company’s novel TCR-engineered T cell therapy products. This newly created role will reside within the Process and Analytical Sciences department and will report to the Associate Director of Analytical Development. Key activities will include the development and execution of analytical methods to support clinical sample analysis, process development and the tech transfer of in-process, release, and stability-indicating assay methods to QC, amongst others.

The ideal candidate will be well-versed in analytical development of cell and gene therapies and a variety of analytical test methods including, but not limited to, multi-color flow cytometry, cellular potency assays, nucleic acid analysis, immuno-assays, etc. The ideal candidate will also have exposure to GMP/ICH guidelines related to the manufacture and testing of human cell and gene therapy products, the ability to thrive in a fast-paced and agile environment and being a team player with the ability to foster productive relationships with internal colleagues and external partners.

RESPONSIBILITIES:

• Responsible for the execution and interpretation of analytical readouts on TCR-engineered T cell processes and products
• Exemplify 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 provide clinical sample analysis, support IND enabling studies, GMP manufacturing, release, and stability testing of TScan’s cellular drug products.
• Integrate with the process development function to implement process improvements based on analytical output
• Act as SME for tech transfer of 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
• Maintain a detailed electronic laboratory notebook and present findings to the team, department, and company, as appropriate.

REQUIREMENTS:

• Scientist: PhD with 2+ years of relevant experience, or MS/BS with 7-10+ years of experience.
• Senior Scientist: PhD with 5+ years of relevant experience, or MS/BS with 12-15+ years of experience.
• Degree emphasis in immunology, cell biology, molecular biology, biochemistry, or related field is preferred.
• Experience developing test strategies for cell-based therapies is preferred, with focus on multi-color flow cytometry analysis and its application on cellular product potency assessment. Prior experiences on clinical sample analysis is higher desirable.
• 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.

About TScan:

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.

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