Principal Scientist, Analytical Lifecycle Management

Role: Principal Scientist in Analytical Lifecycle Management, serving as QC lead for late-stage biologics programs. Responsibilities include developing integrated QC strategies across analytical methods, ensuring regulatory compliance, authoring and reviewing regulatory submissions, overseeing external testing partners, and resolving complex technical issues to support biologics registration and commercialization. The role requires influencing cross-functional teams, providing technical mentorship, and strategic decision-making based on scientific and regulatory judgment. Requirements: PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, Biological Sciences, or related field with 5+ years (PhD), 8+ years (Master’s), or 10+ years (Bachelor’s); extensive experience in GMP-regulated biologics QC, analytical method development, validation, and lifecycle management; strong knowledge of global GMP, ICH, and regulatory standards; excellent communication skills and ability to influence senior stakeholders. Preferred: experience with biologics drug substance and drug product QC strategies, regulatory submissions, external partner oversight, and knowledge of Mandarin. Work setup: not specified; focused on strategic leadership in late-stage biologics development, with an emphasis on quality control, regulatory compliance, and cross-functional collaboration.