Scientist III, Analytical Development and Clinical QC

Job description

As a Scientist III in Analytical Development and Clinical QC at Alexion, you'll be at the forefront of our Late-Stage Analytical team! This pivotal role demands analytical expertise and a proven track record in managing analytical development projects throughout the CMC lifecycle. You'll prioritize multiple projects, collaborating closely with PDCS teams, Regulatory, QA, and external QC laboratories. Develop and implement late-stage analytical strategies, including method transfer, validation, and verification, while authoring regulatory filings with a keen understanding of country-specific requirements. As the analytical functional lead for clinical CMC programs, you'll drive end-to-end analytical activities from Phase 3 through commercialization. Accountabilities: - Lead all aspects of analytical method validations, transfers, and compendia method verifications across all stages of clinical development and method life-cycle stages. - Serve as the analytical lead for CMC programs, focusing on late-stage programs with rigorous cross-functional collaboration. - Develop and implement an analytical end-to-end strategy for key late-stage biologics programs, including control strategy,...