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This role provides strategic leadership for end-to-end analytical development, overseeing control strategies, method development, validation, transfer, and preparation of IND/NDA regulatory documentation. It leads a multidisciplinary analytical team covering physicochemical, bioassay, mass spectrometry, structural characterization and lab operations, while collaborating closely with CMC, process development, manufacturing and quality teams. The position drives analytical strategy and technical innovation, ensures compliance and high-quality output, and manages team performance, mentorship and talent development.
Job Responsibility:
Provides strategic leadership for end-to-end analytical development
Oversees control strategies, method development, validation, transfer, and preparation of IND/NDA regulatory documentation
Leads a multidisciplinary analytical team covering physicochemical, bioassay, mass spectrometry, structural characterization and lab operations
Collaborates closely with CMC, process development, manufacturing and quality teams
Drives analytical strategy and technical innovation
Ensures compliance and high-quality output
Manages team performance, mentorship and talent development
Leads and manages Analytical Science and Development, including Physicochemical & E&L Analysis team, CQA platform team, Bioassay & Immunological Binding Analysis team, Mass Spectrum & Structural Characterization team and Lab operation team
Requirements:
PhD in biological sciences, biochemistry, chemistry or a related field
At least 15 years of technical and managerial experience in the biotech or biopharmaceutical industry
Proven expertise in analytical method development, validation and lifecycle management for biologics
Familiar with FDA and EMA guidelines
Strong bilingual proficiency in English and Mandarin
Team leadership, staff mentoring, and cross‑functional collaboration skills