Senior Specialist, Quality Control Analytical Testing

Purpose & Scope QC Senior Scientist supports analytical testing at QC Analytical Testing (CAR T manufacturing) during clinical/commercial phases. Performs/oversees flow-cytometry and molecular-based testing for stability, validation, critical reagent qualification, training, and critical support. Schedule: Wed–Sat day shift. Required Competencies / Skills Advanced hands‑on analytical experience (flow‑cytometry, molecular techniques) and knowledge of pharmaceutical product characterization/transfer. Ability to accurately apply Global Regulatory and cGMP requirements. Strong technical writing, problem‑solving, and logical thinking. Represent the group on cross‑functional teams. Independently execute in a high‑paced environment; meet deadlines; prioritize multiple projects. Communicate effectively with peers and management (local/global). Education & Experience Bachelor’s degree or equivalent (preferably science) required. Advanced degree preferred. 2–4 years relevant analytical testing/QC experience (preferably regulated environment). Preferred: sterile cell culture, polychromatic flow‑cytometry panels, flow‑cytometry data analysis, ELISA, qPCR. Duties & Responsibilities Perform QC analytical testing (cell‑based in‑vitro flow, ELISA, qPCR for critical reagent concentration) and troubleshoot complex issues. Develop/write/execute methods, protocols, reports, and related documents; prepare continuous improvement projects. Peer review testing data; ensure compliance with procedures and cGMP; complete reviews per release timelines. Support document revisions, CAPA, and investigation/deviation tasks. Benefits Health coverage (medical/pharmacy/dental/vision), wellbeing programs (incl. EAP), 401(k), disability and life insurance, and related financial protections. Paid time off options and additional eligibility‑based time off (per plan terms). #J-18808-Ljbffr