Careers

Head of Analytics: Cell Therapy & Non-Viral Vector (DIR06-1)

LOCATION: Waltham, MA

POSITION SUMMARY:

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 Director of Analytical Development to lead efforts in implementing new technologies and developing test methods for the company’s products.  This role will reside within Process Sciences and will report to the Vice President of Process Sciences. Key activities will include leading of method development and optimization for testing of pivotal/late-stage clinical materials including non-viral vector drug substance and cellular drug product, identification and implementation of new instrumentation and data analysis platforms, coordinating analytical support and training for process and vector development, harmonization of novel analytics across research & development functions, 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 and strong leader 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, LNPs, 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.

RESPONSIBILITIES:

  • As a senior leader within Process Sciences, provide strategic, technical and scientific leadership to the Analytical Development team. Create an environment of scientific excellence and innovation, and drive quality principles across the development teams.
  • Continue to build and manage team, support analytical testing for process & vector development teams, manage tech transfer to TScan QC team as well as review of external test methods and specifications.
  • Review and implement technical improvements to method design, instrumentation, and operational execution. Provide guidance, create, and implement strategic systems to improve workflows within analytical development including onboarding of digital workflows, automated processes, and other lab practices.
  • Accountable for leading the analytical development team to define and implement method improvements across the organization
  • Represent TScan to regulatory agencies by supplying verbal or written information and/or participation in face-to-face meetings for responsible activities.
  • Collaborate closely with other key line functions and communicate complex data/decisions within the department and to program teams and provide effective technical and business leadership at the R&D/CMC interface.
  • Own the development of product control strategy and partner with TScan’s quality group on the testing strategy and life-cycle management for vector drug substance, cellular drug product, and future product modalities.
  • Evaluate and introduce new analytical technology while assuring harmonization with federal regulations, guidance documents and TScan’s overall product testing strategy.
  • Develop and communicate cost estimates, business plans, timelines, and contingency plan.
  • Identify and recruit resources to accomplish project and departmental objectives within agreed time scope and operating in a transparent environment.
  • Own the creation of a high performing team with a strong individual initiative, deep scientific curiosity, and natural environment of working together collaboratively.

REQUIREMENTS:

  • PhD with 10+ 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

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.

Apply Now