Legend Biotech pioneers cell therapies from its advanced Raritan, NJ facility, where the QC Analyst I role anchors product integrity across clinical and commercial pipelines. This position safeguards the efficacy of innovative CAR-T treatments by executing stringent quality assessments that comply with FDA regulations and drive operational excellence. Daily responsibilities encompass performing wet chemistry assays, microbial limit testing, and potency evaluations on cell therapy batches using HPLC, flow cytometry, and ELISA platforms. The analyst documents deviations in real-time via electronic batch records, collaborates with MSAT teams to troubleshoot process anomalies, and supports validation of new analytical methods. Routine calibration of lab instruments and inventory management of reagents ensure seamless workflow, while participation in CAPA investigations strengthens continuous improvement initiatives. Candidates must hold a Bachelor's degree in Biology, Chemistry, or a related life science field, coupled with 1-2 years of hands-on experience in a GMP-regulated biotech or pharmaceutical lab. Proficiency in cGMP documentation, LIMS systems, and compendial methods is required, alongside familiarity with USP guidelines for biologics testing. Essential competencies include sharp analytical thinking for interpreting complex datasets, meticulous attention to detail in protocol adherence, and effective communication for cross-functional reporting. Adaptability to shifting priorities in a dynamic production environment, plus foundational knowledge of cell-based assays, distinguish top performers. Legend Biotech fosters a collaborative culture emphasizing innovation and employee development within multidisciplinary teams at its Raritan campus. Professionals thrive amid state-of-the-art labs, with avenues for skill enhancement through targeted training and project leadership opportunities. The package features competitive compensation aligned with market rates, comprehensive health coverage, generous PTO, and 401(k) matching to support work-life balance.