LOCATION: Waltham, MA
TScan Therapeutics is a clinical-stage biotech with in-house manufacturing and analytical testing capabilities seeking to revolutionize life changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced Quality Assurance professional to join our team as Senior Specialist, Quality Systems, supporting our novel target identification and validation workflow in house. The ideal candidate should have relevant experience in quality compliance, and enjoy fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.
- Manage and own TScan’s Vendor Management Program and ensure all GxP vendors are qualified as per approved procedures
- Participate in Vendor audits as required
- Manage Raw Material Assessment program
- Assist in managing TScan’s Training Program
- Assist in managing Deviation, CAPA, Change Control programs as needed
- Perform as an SME for TScan’s future electronic Quality Management System implementation and validation
- Author or revise applicable controlled documents related to quality systems
- Generate, Issue, and reconcile controlled documents for the GMP manufacturing environment
- Assists in the identification and implementation of continuous improvement opportunities
- Adhere to all cGMPs, compliance/regulatory mandates and quality requirements
- Practice safe work habits and adhere to TScan’s safety procedures and guidelines
- Perform other related duties as assigned to meet departmental and Company objectives
- Bachelor’s degree in a relevant discipline with a minimum of 3 years of experience in FDA-regulated industry
- Experience in reviewing and creating controlled documents; technical writing skills a plus
- Understanding of GxPs and Quality Systems and how they apply to specific responsibilities
- Must possess strong documentation and communication skills
- Experience with Veeva DMS, QMS or other electronic systems is a plus
- Certification in Vendor Management and/or Audit is a plus
- Must be able to read, write and speak English fluently
- Must be able to lift and transport (using carts or wheelies) packages weighing up to 50 pounds
- Extensive walking throughout the facility will be required
- Must be able to use a company-issued computer and have at least intermediate skills in Microsoft Word, Excel, Outlook, and PowerPoint programs needed to perform job
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!