Senior Scientist, Analytical Development

Position Summary:

TScan Therapeutics is a clinical stage cell therapy company seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a new member at the level of Senior Scientist in Analytical Development for the companys novel TCR-engineered T cell therapy products. This role will reside within the Process and Analytical Sciences department and report to the Associate Director of Analytical Development. Key activities will include the development, qualification and technology transfer of in-process, release, and stability-indicating analytical methods to support GMP production by internal department and external partners

The ideal candidate will be highly experienced in the development, qualification and validation of analytical methods of cell therapies using 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 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:

• Supports the qualification of analytical methods used for the release and stability testing of Tscans TCR-T cell products

• Authors and reviews technical documentation (method development reports and SOPs) to support method transfer to third party and internal QC laboratories.

• Oversees the transfer and qualification of TCR-T analytical methods to third party testing GMP testing laboratories

• Oversees drug product stability, reference standard and critical reagent programs at third party laboratories

• Provides technical support for third-party testing laboratories

• Resolves out-of-specifications, deviations and other laboratory investigations

• Works closely and collaboratively with Tscan colleagues to manage CDMOs performing GMP TCR-T cell manufacturing and testing

• Assists quality as SME in developing QC testing strategies and validation efforts

• Supports clinical sample analysis, IND enabling studies, GMP manufacturing, release, and stability testing of TScans cellular drug products.

• Authors relevant sections in regulatory filings

• Maintains detailed documentation and presents findings to the team, department, and company, as appropriate.

Requirements:

• PhD with 5+ years of relevant cell therapy industry experience, or MS with 10+ years of industry 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. Prior experience in internal and external technical transfer, contract management and clinical sample analysis and QC is highly desirable.

• Scientific creativity, critical thinking, ability to innovate, and analytical problem solving.

• Excellent communication skills (both written and oral) are 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 analytical methods is desirable.

• Up to 50% travel to Contract Manufacturing and Testing Sites with some bench work for technical transfer is required.

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.