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 of CMC Supply Chain to lead our Clinical Supply Chain function. This newly created role residing in the Technical Development and Manufacturing team will report to the Associate VP of CMC. Key activities for the role include managing external manufacturers, developing, and managing the donor-to-patient supply chain, managing budgets, and participating on cross-functional teams.
The ideal candidate will (i) have a strong background in clinical stage external manufacturing and supply chain for cell therapy, gene therapy, or orphan drugs, (ii) have experience with cell therapy patient-to-patient chain of custody and chain of integrity (iii) be a steadfast problem solver who is energized by a fast-paced, lean and agile environment; and (iv) be a team player who can foster productive relationships with internal colleagues and with external partners.
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 move novel TCRs into clinical development.
- Provide strategic direction to TScan’s Clinical Procurement and Supply Chain function, ensuring the company is well-positioned to meet development and clinical materials production needs
- Develop and manage TScan’s donor-to-patient supply chain, including donor-to-patient logistics and chain of custody.
- Provide oversight of external manufacturers including participating in or leading vendor selection processes, acting as TScan’s primary point of contact with the vendor, overseeing contract negotiations, leading cross-functional external manufacturing teams, and working with Quality to resolve any vendor related quality issues.
- Define, execute and lead strategic initiatives for supply chain forecasting and management, including cost management and risk reduction opportunities, inventory optimization and other activities related to warehousing of materials and materials management improvements (including but not limited to inventory management systems development).
- Manage budget tracking and assist in business operations planning for overall department.
- Bachelor’s degree in Life Sciences, Engineering, Pharmacy, Supply Chain/Logistics or related discipline. Advanced degree preferred.
- 8+ years of pharmaceutical experience with 5+ years experience in Cell and Gene Therapy or Orphan drug clinical supply chain management, commercial supply chain management, Cell Therapy Development, Clinical Operations, CMC development, or related discipline. Deep experience working with multidisciplinary project teams and managing relationships with CMOs/CROs preferred.
- Ability to influence stakeholders from many technical disciplines and at many levels
- Ability to apply multiple lenses to analyze and represent complex interdependencies, scenarios, and tradeoffs
- Ability to lead and influence in a matrix organization
- Leadership skills and strategic problem solving ability; ability to predict issues and identify solutions
- Excellent organizational skills with proactive management of multiple tasks of varied complexity simultaneously
- Excellent communication skills (both written and oral)
- Experience drafting manufacturing documentation and supporting documentation for regulatory filings is strongly desired
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 as well as 4000 square feet of GMP manufacturing space provides an environment that supports innovation, camaraderie and professionalism. We are driven, passionate, fun, flexible and team oriented. Sound like you? Apply today.