Responsible for the development and optimization of purification processes for company project proteins, antigens, and reference standards. Lead the team in completing preliminary developability assessment, formulation screening, and validation.
Support IND projects in cell line construction, culture, purification, formulation process development, and sample preparation. Ensure experimental data is standardized, complete, and traceable.
Compile pharmaceutical data,撰写 developability and purification study reports, participate in drug design and risk assessment, and track technological advancements.
Propose solutions for experimental anomalies, collaborate in cross-departmental communication, optimize project progress, and resolve technical issues in early research or CMC collaborations.
Complete other tasks assigned by superiors.
Master's degree or higher in Molecular Biology, Biochemistry, Bioengineering, or related fields.
Approximately 10 years of protein purification experience, proficient in various chromatography techniques (affinity, ion exchange, hydrophobic interaction, size exclusion, etc.), as well as purification process development, pilot-scale scale-up, and validation.
Experience related to IND filing, capable of independently leading a team to complete process development and transfer.
Strong communication and presentation skills, emphasis on teamwork, able to efficiently drive project progress.
Experience in early-stage developability assessment is preferred.