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 an Associate Director/Director in Analytical Development to lead efforts in developing test methods for the company’s novel TCR-engineered T cell therapy products. This role will reside within CMC and will report to the Associate Vice President of Process & Analytical Development. Key activities will include leading of method development and optimization for testing of pivotal/late-stage clinical materials, identification and implementation of new instrumentation and data analysis platforms, coordinating support for process development, documentation development and archive management, authorship of regulatory filings, method transfer to QC, qualification support, and acting as an analytical SME to external vendors, amongst others.
The ideal candidate will (i) have a strong background in 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 ideal candidate would be well-versed in a variety of analytical test methods for materials including, but not limited to, engineered human cell therapy products, nucleic acids, recombinant proteins, and monoclonal antibodies. Experience with DoE-based experimental design and in developing robust and meaningful cellular potency assays with orthogonal methods is highly desired. Experience with interpretation of next-generation sequencing data, and high-throughput protein / analyte analysis systems, as well as exposure to the manufacture & testing of viral and non-viral vectors are a plus.
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.
- As a senior leader within Analytical Development, provide strategic, technical, and scientific leadership to the team
- Continue to build and manage team, drive analytical testing support for process development, and product characterization
- Review and implement technical improvements to method design, instrumentation, and operational execution
- Accountable for leading the analytical development team to define and implement method improvements across the organization
- Oversee method transfer and provide technical support to QC
- Together with QA, oversee analytical data management, integration, and archiving
- Review/approve study protocols and reports, manage internal and QA review and incorporate regulatory documents
- Accountable for integration of method development and qualification reports into regulatory filings
- Collaborate closely with other key line functions and communicate complex data/decisions within the department and to program teams
- PhD with 10-12+ years of relevant experience; degree emphasis in biological sciences, biochemistry, cell biology, or related field is preferred
- Strong background in analytical method development for the characterization of novel cell & gene therapies
- Scientific creativity, critical thinking, ability to innovate, and analytical problem solving
- Excellent communication skills (both written and oral)
- Experience drafting manufacturing documentation and supporting documentation for regulatory filings
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.