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 experienced Quality Control (QC) professional to join our team as a QC Analyst. supporting our novel target identification and validation workflow in house. The ideal candidate should have relevant experience in Gene Therapy products, Quality Control, and enjoy fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.
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.
- Plans and performs Bio-Analytical testing such as Flow Cytometry, ELISA, qPCR, cell count, (incoming, in-process and final product release testing).
- Collaborates with Product Analytical Development team in the transfer of analytical assays to QC.
- Performs Microbiological/sterility testing and activities in compliance with applicable SOPs and procedures
- Ensures maintenance and control of QC test samples
- Maintains, controls, reagents, and reference standards to support testing
- Maintains retain and stability samples
- Reviews/approves data generated by other team members
- Train others
- Contributes to the setup and optimization of the QC and Microbiology labs
- Executes validation/optimization of test methods as per appropriate protocols
- Contributes to OOS/OOT and deviation investigations
- Participates in deviation investigation/CAPA implementation in a timely manner
- Supports and assists TSCAN Quality Assurance and Quality Control projects
- Continually identifies areas for improvements in project work
- Supports tracking and trending systems, and programs which assist in the testing, evaluation and monitoring of quality and efficiency
- Reviews QC documentation, to ensure completeness, accuracy, consistency, and clarity
- Generates/revises protocols/reports, SOPs, forms, laboratory data sheets
- Reviews, maintains QC laboratory documentation (logbooks, forms etc.)
- Maintains the QC/Microbiology labs and associated equipment daily
- Supports the Product Analytical Development team, where applicable
- BA or MS in biology, chemistry, biochemistry, microbiology, or other related science
- 3-6+ years of experience in QC – pharmaceutical, biologics, microbiology
- Gene therapy product experience preferred
- Industry knowledge of cGMP and GLP
- Knowledge of other QC data systems (preferred)
- Knowledge of bioassay test methods, as appropriate
- Ability to communicate clearly and work collaboratively with a variety of individuals in various aspects of TSCAN operations
- Detail-oriented with expertise in problem solving and solid decision-making abilities
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.