LOCATION: Waltham, MA
TScan is seeking an experienced scientist/engineer to build the team and lead efforts to develop an autologous human TCR-engineered T cell product manufacturing process. The individual hired will be an integral part of TScan’s Technology Development and Manufacturing team, which is preparing for the clinical development of new T cell therapy targets discovered using proprietary TScan platform technologies.
The ideal candidate will (i) have a strong background in human T cell product manufacturing; (ii) be energized 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.
Candidate will be well-versed in industrial cell process development methods, process instrumentation and analytical devices, with primary focus on cell product manufacturing applications. Working with TScan Preclinical team, candidate and PD/AD team will be responsible for developing and transferring detailed methods with SOPs for TScan cell processing Unit Operations. This position will be based in Waltham, MA and will initially involve hands-on lab work with help from more junior team members under direct supervision and in a matrix-managed fashion.
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 advance novel TCRs into clinical development.
JOB RESPONSIBILITIES INCLUDE:
- Lead efforts to design and implement human T cell processing methods for manufacturing TCR-engineered T cell products.
- Develop methods and write SOPs for specified manufacturing process Unit Operations.
- Help develop and apply generic and TCR-specific cell product analytical methods and release assays.
- Help establish and manage relationships with external CDMOs who specialize in cell manufacturing and guide the tech transfer to chosen external CMO, or to internal manufacturing facility and team.
- Contribute to CMC section of INDs and support TScan filings in meetings with regulatory authorities.
- D. in Molecular Biology, Immunology, or a closely-related field.
- 2-3 years of postdoctoral experience, with several years of relevant industry experience manufacturing human cell products would be ideal.
- Understand material cGMP quality requirements and be familiar with evolving regulatory guidelines for cell product manufacturing. Experience developing and executing manufacturing strategies for human primary T cell products is preferred.
- Experience with T cell genome-editing and targeted integration methodologies would be desirable.
- Demonstrated scientific creativity, critical thinking, ability to innovate, and analytical problem solving.
- Excellent communication skills, both written and oral.
- Previous experience with scalable microfluidic cell processing methods and devices is highly desirable.
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Director/Sr. Director of Cell Process Development