Principal Scientist, Separation Methods Expert, Analytical Science and Technology (AS&T), Vertex Pharmaceuticals (Boston)

Role: Principal Scientist specializing in Separation Methods within Analytical Science & Technology for late-stage and commercial biologics. Objectives include managing analytical method lifecycle stages—remediation, validation, transfer—and supporting troubleshooting, investigations, and regulatory submissions. Responsibilities encompass cross-functional collaboration with internal teams and external vendors, overseeing quality events related to analytical methods, authoring technical documents, and ensuring compliance with cGMP and global quality standards. Qualifications: PhD, Master's, or Bachelor's in Biochemistry, Chemical Engineering, or related field; 5+ years (PhD), 8+ years (Master's), or 10+ years (Bachelor's) of relevant experience. Expertise in chromatographic, electrophoretic, and impurity separation methods for biologics, with knowledge of regulatory guidelines (ICH, USP/EP/JP), and familiarity with techniques like peptide mapping and mass spectrometry. Strong statistical analysis skills and excellent technical communication are preferred. High-Value: Focus on biologics (protein-based), late-stage and commercial, with responsibilities linked to method validation, troubleshooting, and regulatory support. Hybrid or onsite work; no travel specified.