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 Assurance (QA) professional to join our team as the QA Sr. Manager/Manager, supporting our novel target identification and validation workflow in house. The ideal candidate should have relevant experience in Quality Assurance, cGMP compliance, and enjoy fast-paced, collaborative and vibrant startup culture. A team player with a sense of urgency will thrive in this role.
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.
- Ensures the Quality Management System (QMS) is capable and effective at all levels; achieves and maintains compliance to US and international standards at our Waltham, MA facility
- Interfaces with external personnel (vendors, partners, and regulatory bodies) and internal personnel (management and staff) to drive Quality Assurance tasks and milestones
- Responsible for audit planning, conduct, findings, responses, and corrective and preventative actions
- Performs quality system internal audits and drives improvements within the local quality system as needed
- Monitors the performance of the local quality systems and reports to management
- Designs and implements a phase-appropriate QMS for a gene therapy/biologic product in an organization with internal manufacturing
- Supports quality management sub-systems to achieve continual compliance and consistency TScan’s Quality Management System (QMS) that includes but it is not limited to: management reviews, deviations, non-conforming materials management, CAPA, change control/management, document control, process control, complaints, training, etc.
- Fosters an open environment of continuous improvement
- Influences effective compliance-based decisions with cross functional communication and team building skills
- Assimilates relevant technical, regulatory, and compliance information to formulate suitable strategies and tactics to satisfactorily resolve complex problems
- Manages daily QA operational activities
- Manages personnel and provides technical guidance and support
- Bachelor’s degree required; ASQ or RAPS certification is a plus
- 10+ years of quality experience in the biotech and/or pharmaceutical industry
- Working knowledge of compliance best practices for gene therapy or cell-based products
- Strong knowledge of US Quality System and International standard requirements
- Experience dealing directly with FDA and notified bodies and knowledge of appropriate FDA, ISO, and global regulations regarding quality systems is a plus
- Ability to effectively communicate with a broad spectrum of people having varying backgrounds, education, and experience
- Strong organizational and computer (Microsoft Word, Excel, PowerPoint, Adobe Acrobat) skills required
- Ability to communicate clearly with a variety of individuals in various aspects of TScan operations
- Detail-oriented with expertise in problem solving and solid decision-making abilities
- Strong written and verbal communication skills are essential
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.