Senior Specialist, QC Analytical, Cell Therapy

Role: Senior Specialist in QC Analytical focusing on cell therapy products, supporting in-process, final, and stability testing. Responsibilities include method transfer/validation, troubleshooting, data review, GMP documentation, and continuous improvement initiatives. Mentors team members on test methods and processes. Requirements: Bachelor's degree in science or bioanalytical field; 4+ years of relevant QC or analytical testing experience, preferably in regulated environments. Skills: strong understanding of cGMP, data verification, technical writing, problem-solving, and familiarity with LIMS, ELN, and data analysis systems. High-value specifics: cell and molecular biology techniques (e.g., flow cytometry, qPCR, ELISA), cell therapy modalities, regulated GxP environment, quality control, and documentation. Collaboration involves cross-functional teams within QC and manufacturing. Work setup: shift-based (Sunday-Wednesday, 1:30pm-11:30pm) with potential for remote or onsite based on company policies; travel is not specified.