QC Analyst I/II

Role: QC Analyst in the Quality Operations team responsible for performing GMP-compliant QC testing of autologous CAR-T cell therapy products for clinical trials and commercial manufacturing. Responsibilities include executing analytical tests on raw materials, in-process, and final products, ensuring compliance with GMP standards, reviewing laboratory data, and maintaining documentation via electronic systems (LIMS). The role involves collaboration with QA, Manufacturing, and Development teams, with routine exposure to biological materials and hazardous chemicals. Requirements: Bachelor's in Science, Engineering, or related field; at least 1 year of relevant experience, preferably in biopharma QC; proficiency in aseptic techniques, GMP regulations, and biosafety practices. Preferred skills include experience with CAR-T testing methods and working in a regulated cGMP environment. High-value specifics include involvement with cell therapy products, particularly CAR-T, in a biologics manufacturing setting. The position may require shift work, occasional travel to partner sites, and adherence to safety and regulatory standards.