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 Sr. Manager/Manager-Quality Control, supporting our novel target identification and validation workflow in house. The ideal candidate should have relevant experience in biotech, gene therapy, pharmaceutical industries and enjoy fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.
The Sr. Manager/Manager, Quality Control position, leads a small team of 2-3 QC associates including Microbiology associates, that executes Sample Management activities including testing, control, receipt, and distribution of product, intermediates, raw materials samples, sample retention, reference samples, and stability samples. The Sr. Manager/Manager is a hands-on manager that can support and execute QC testing, as needed.
The Manager QC position interacts regularly with TSCAN’s Quality Assurance, Product Analytical Development, Manufacturing, Facilities, as well as TSCAN’s external test laboratories, where applicable. This position supports the transfer, qualification and validation of all QC analytical methods and activities necessary to qualify our new Waltham gene therapy manufacturing facility.
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.
- Manages, coaches, and develops the team of QC and Microbiology associates/analysts
- Serves as the QC/Microbiology Management Subject Matter Expert (SME)
- Leads set up and qualification of a GMP compliant QC and Microbiology laboratory including sample receipt, testing, retains
- Manages staff, sets up schedules, monitors QC daily testing activities including daily QC laboratory operational maintenance
- Authors, reviews, approves QC related documentation (SOPs, reports, etc.), provides documentation support to QA, as needed
- Manages QC Quality records including but not limited to Deviations, Investigations, CAPAs, Change Control, and ensures that all related activities are completed in a timely manner
- Triages, delegates and manages high priority issues from cross-functional leads
- Attends functional meetings, Deviations, Materials, Manufacturing, Facilities, meetings to discuss ongoing work and issues escalations
- Manages and approves QC sample management activities
- Manages all sample shipments to and from TSCAN and the raw material contact testing, where applicable
- Receives testing results from any contract test labs (where applicable) and reviews and approves QC testing documentation
- Establishes routine operations to govern activities in the QC Sample management. Activities include, scheduling sample testing, ordering suppliers, overseeing/monitoring QC equipment maintenance and calibration, performing documentation reviews and escalating any issues to QA appropriately, and in a timely manner
- Collaborates with the Product Analytical Development and facilitates analytical method transfer activities to QC
- Coordinates with Manufacturing the product test sample submission and testing
- Ensures all QC staff is trained according to job specific requirements
- Requires a bachelor’s degree in Biochemistry, Microbiology, Molecular and Cellular Biology or Biology
- Quality Control experience in Biotech, Pharmaceutical industry supporting cGMP areas, including QC sample testing and stability program management
- 7+ years of relevant biotech/pharma industry experience
- 3+ years direct experience supervising /managing direct reports
- Strong cGMP skills
- Experience leading people and/or projects with history of achieving results and outstanding outcomes
- Strong communications skills, team player, negotiation skills
- Experience with implementing and overseeing sample management programs
- Experience working in a laboratory environment
- Experience participating and/or supporting regulatory inspections (preferred)
- Project Management skills
- Able to lead, mentor and inspire others
- Experience in gene therapy cGMP manufacturing and testing
- Role model for TSCAN company values.
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 over 10,000 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.