Linjie Han

Senior Director (Analytical Development and Quality Control) @ Sunshine Guojian Pharmaceutical (Shanghai)

About

Experienced ADQC executive with ~12 years of biopharmaceutical experience across analytical development, quality control, and CMC/pharmaceutical strategy for biologics, including mAbs, bispecifics, trispecifics, fusion proteins, multispecific antibody constructs, and ADCs. Expertise includes end-to-end analytical leadership, key quality attributes (CQAs), impurity analysis, mass spectrometry-based protein characterization, method development and validation, regulatory support, quality systems, cross-functional collaboration, and team leadership.1. ~12 years of experience in analytical development, QC, process/product characterization, project management, and people leadership2. Strong knowledge of CMC analytical strategy and regulatory requirements for biologics3. Deep expertise in mass spectrometry, including peptide mapping, intact/reduced/subunit/native mass analysis, and ion mobility MS4. Hands-on experience with HPLC (SEC, CEX, HIC, RPLC) and CE (CE-SDS, icIEF)5. Skilled in analytical method development, qualification, validation, and transfer under CDE, FDA, and ICH guidelines6. Proven success leading analytical teams and supporting early- and late-stage biologics programsExperienced in extended characterization, IND/IMPD Module 3 authoring/review, and health authority responses7. Strong working knowledge of SOPs, cGMP, and regulated laboratory operations8. Author of ~18 research articles, 1 book chapter, and multiple oral/poster presentations

Country

City

China

Industry

Pharmaceuticals

Skill

Mass Spectrometry, Ion mobility mass spectrometry, LC-MS, Protein-protein Interactions, Fluorescence Spectroscopy, Analytical Chemistry, Protein Folding, Size exclusion chromatography, Dialysis, Gel filtration, Circular dichroism, Differential scanning calorimetry, Protein conformation characterization, Intact protein mass analysis (up to 800 kDa), Protein-ligand interactions, High Throughput Screening, Assay Development, Circular Dichroism, Differential Scanning Calorimetry, UV/Vis

Experience

Senior Director (Analytical Development and Quality Control)

Sunshine Guojian Pharmaceutical (Shanghai)

2025-8 - Present · 1 yr 2 mos

Shanghai, China

-Lead ADQC for biologics programs (mAbs/Bispecifics/Trispecifics/Fusion proteins/Multispecific Antibody Constructs), providing integrated planning and end-to-end analytical and quality oversight across development, regulatory submission, and lifecycle management. -Oversee method development, validation, transfer, release testing, stability studies, specification setting, and analytical issue resolution. -Provide CMC and analytical leadership across key quality attributes, control strategy, technical development, impurity analysis, and product characterization for multiple biologics modalities. -Strengthen quality systems through SOP harmonization, process standardization, QA alignment, and inspection readiness. -Drive cross-functional collaboration across R&D, process development, formulation, manufacturing, QA, regulatory, IT, and external partners. -Advance digitalization and efficiency through LIMS/ELN planning, workflow optimization, automation, and AI-supported data analysis. -Build and lead a strong team (~50 employees) through talent development, capability building, and strengthening core analytical expertise. -Manage resources, budgets, lab operations, and relocation activities while balancing compliance, quality, timelines, and efficiency.