Director, Quality Control

Career Opportunities with TScan Therapeutics A great place to work.   Careers At TScan Therapeutics Current job opportunities are posted here as they become available.     Back To Openings     Director, Quality Control Department: 10 - Quality Control Location: Waltham, MA START YOUR APPLICATION Position Summary: TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced professional to join our team as Director of QC, supporting release, characterization, and environmental monitoring (EM) testing for cellular drug products manufactured internally at TScan. Reporting to the Associate Vice President of QC and AD, the ideal candidate should have relevant experience in compendial, cellular, molecular, and environmental monitoring in a cGMP facility, and enjoy fast-paced, collaborative, and vibrant culture. A team player with a sense of urgency will thrive in this role. Responsibilities: Maintain a culture of constant improvement and compliance with cGMP Manage QC team execution of internal STAT and release testing for disposition of Phase 1/2 clinical trial drug products per target release timing Ensure GMP lab is maintained in a constant state of compliance and inspection readiness Support QMS compliance through timely review of documents and ensuring QC support of Quality/CMC documentation Drive sense of urgency through effective meeting cadence and scope as well as appropriate delegation of tasks and duties Support personnel development including efficient cross training and organizational design of QC release team Manage QC QMR metrics reporting to Senior Leadership Team Requirements: Education: Masters and 12+ years of direct cGMP experience OR BS and 15+ years OR PhD and 10+ years Experience in cell therapy manufacturing for clinical stage products strongly preferred Deep knowledge of USP, EP, ICH, and Cell Therapy regulatory guidance Management of cross-trained multi-disciplinary teams in an active cGMP release testing environment including responsibility for COA generation and approval Experience developing and managing stability programs in the clinical environment Able to execute responsibilities at the Director level Experience managing multi-shift operations preferred About TScan: TScan Therapeutics is a fully integrated, next-generation TCR-T cell therapy company. Founded in 2018, TScan�s platform was developed by Stephen Elledge, Ph.D., and Tomasz Kula, Ph.D., at Brigham and Women�s Hospital and Harvard Medical School. TScan�s transformative platform enables rapid discovery of TCRs and targets for engineered T cell therapy. This technology is extremely versatile and is applicable across multiple therapeutic areas beyond cancers, including autoimmune disorders and infectious diseases. Do YOU have the anatomy of a TScanner? Our talented, compassionate, and intelligent team is what makes TScan a Top Place to Work (as ranked by The Boston Globe). Our state-of-the-art offices with over 70,000 square feet of premium lab space, including an internal GMP manufacturing suite, are an environment that supports innovation, camaraderie, and professionalism. We are passionate, fun, flexible, and team oriented. Sound like you? Apply today. EEO Statement TScan is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. TScan provides reasonable accommodations to qualified applicants and employees with...