Senior Scientist, Analytical Science

Job Summary

Leading method transfers and validations in a hybrid-remote environment, the full-time Senior Scientist, Analytical Science will manage QC deliverables for cellular drug substance and drug product development while collaborating with external stakeholders and ensuring compliance with regulatory requirements.

Key responsibilities

• Support QC deliverables for cellular drug substance and drug product development in late-stage clinical development
• Review outsourced GMP work and serve as Lead SME for method validations and assay control establishment
• Independently resolve technical issues and collaborate with internal and external teams to address challenges

Required qualifications

• 5+ years of experience in Quality Control with a Master's Degree or a PhD with 2 years of relevant QC experience, or 8+ years with a Bachelor's Degree
• Experience with method validations and USP method verification in late-stage clinical development
• Excellent knowledge of cGMP requirements and relevant guidelines (EMA, FDA, ICH) for QC testing
• Hands-on experience and deep understanding of Flow Cytometry
• Proven expertise in analytical method lifecycle management, including method approval, verification, validation, and transfer