Duties/Responsibilities: Perform and verse GMP testing of raw materials, including but not limited to identity, sterility, endotoxin, bioburden, mycoplasma, pH, osmolality, and compendial testing Execute material qualification activities for new vendors, materials, and alternate suppliers Review and approve raw material test results and disposition materials in accordance with internal procedures Ensure timely testing and release to support manufacturing schedules Author, review, and approve GMP documentation including SOPs, test methods, protocols, reports, deviations, CAPAs and change controls Maintainer accurate and compliant laboratory records in LIMS, ELN, and paper-based systems Support internal, external, and regulatory audits (FDA, EMA, etc.) Act as a subject matter expert (SME) for raw material testing methods and regulatory expectations Troubleshoot assay failures, out-of-specification (OOS, and out-of-trend (OOT) results Lead or support method transfers, verifications, and validations for raw material assays Evaluate supplier documentation including BSE/TSE, CoAs, COC, COI, technical packages, SDS and quality agreements Identify opportunities to improve testing efficiency, data integrity, and compliance Support implementation of new technologies, methods, and systems Participate in cross-functional teams with QA, Manufacturing, Materials Management and Product Development Coordinate sample shipments for contract testing labs for quality control. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjögren's Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases.