Senior Specialist, QC Analytical, Cell Therapy

Role: Senior Specialist in QC Analytical for Cell Therapy, supporting testing of in-process, final, and stability samples within a regulated biopharma environment. Responsibilities: perform method transfer, validation, routine testing, troubleshooting, data review, GMP documentation review, and lead continuous improvement projects; mentor team members on QC processes. Requirements: Bachelor's degree in science; 4+ years of relevant analytical QC experience, preferably in cell and molecular biology techniques (e.g., flow cytometry, qPCR, ELISA); strong understanding of cGMP and regulatory requirements; proficiency in LIMS, ELN, and data analysis systems. Preferred: experience in cell therapy bioprocessing and working in a highly regulated setting. High-value specifics: focus on cell therapy, process validation, GMP compliance, analytical testing, and troubleshooting in a fast-paced, regulated lab. Work setup: shift Sunday to Wednesday, 1:30 pm to 11:30 pm, in NJ, US, with potential for cross-functional collaboration.