Director, Quality Control

TScan Therapeutics•Waltham, MA

11d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Management of multi-shift operations preferred

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