Associate Director of Biochemical and Cell-Based Bioassay Development

Position Summary

Based on business needs, the Associate Director of Biochemical and Cell-Based Bioassay Development position is established to lead biochemical and cell-based bioassay platform development and project support for antibody-based biologics. This role is primarily responsible for development, optimization, qualification, validation, transfer, and lifecycle management of cell-based potency assays, functional bioassays, and impurity assays including HCP, residual Protein A, and residual DNA. The position provides scientifically sound, reliable, and regulatory-compliant analytical data and technical support for cell line development, process development, product characterization, stability studies, comparability studies, and regulatory submissions in China, the United States, and Europe

Your main responsibilities are:

• Lead development, optimization, qualification, validation, transfer, and lifecycle management of cell-based potency assays for antibody-related molecules.
• Establish appropriate bioactivity and functional assay strategies based on product mechanism of action to support critical quality attribute assessment.
• Establish and optimize cell-based functional assays, including but not limited to reporter gene assays, cell proliferation assays, cytotoxicity assays, neutralization assays, ADCC, CDC, receptor binding assays, and signaling pathway-related assays.
• Lead development, optimization, qualification, validation, transfer, and continuous improvement of impurity assays, including HCP, residual Protein A, and residual DNA assays.
• Support cell line development, process development, formulation development, product characterization, stability studies, and comparability studies by providing timely, accurate, reliable analytical data and scientific judgment.
• Prepare and review analytical method development protocols, validation protocols, method transfer protocols, technical reports, SOPs, and related quality documents.
• Lead or support preparation, review, and response to questions for biochemical assays, cell-based potency assays, and impurity testing sections in regulatory submissions for China, the United States, and Europe.
• Lead technical investigations, root cause analyses, risk assessments, and CAPA development for cell-based bioassays and biochemical assays.
• Participate in OOS/OOT, deviations, changes, method deviations, and laboratory investigations, and provide scientific and technical support.