Senior Manager, Analytical Development

Role: Senior Manager, Analytical Development, leading analytical method development and validation for Aurinia's drug substance and drug product (Lupkynis), with a focus on small and large molecules. Responsibilities: oversee external analytical activities, troubleshoot method issues, review protocols, facilitate technical transfers, and support regulatory filings. Drive innovation by integrating new technologies, collaborate with CDMOs/CROs, and contribute to late-stage CMC development, including impurity control and risk assessments. Requirements: minimum 10 years' industry experience supporting analytical development in a matrix environment; BS/MS in Chemistry or related field, Ph.D. preferred. Expertise in dissolution testing, analytical troubleshooting, and validation across preclinical, IND, or clinical phases. High-value: biologics or small molecules, oral dosage forms, late-stage CMC, regulatory filings, and global development. Work setup: role involves up to 25% travel to external sites.