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Responsibilities :

• Responsible for upstream / downstream biopharmaceutical process development and optimization (including but not limited to cell culture and purification processes) for monoclonal antibodies, bispecific antibodies, fusion proteins, etc.
• Explore and develop novel process platforms, including continuous processing, high-density cell culture, and Process Analytical Technology (PAT).
• Participate in process technology transfer (Tech Transfer) and provide scale-up manufacturing support.
• Prepare relevant technical documents to support IND / BLA filings.
• Conduct experiments in compliance with GLP (Good Laboratory Practice) requirements, ensuring traceability and regulatory compliance in R&D processes.
• Participate in laboratory 5S operations and maintenance.

Requirements :

• Master's degree or higher in Bioengineering, Biotechnology, Chemical Engingeering, Pharmaceutical Engineering, or related fields.
• Hands-on experience in mammalian cell culture or protein purification is preferred.
• Familiarity with statistical tools such as DoE (Design of Experiments) and proficiency in process modeling and data analysis (JMP, Minitab, etc.).
• Knowledge of global biopharmaceutical regulations (ICH, USP, EP) and industry guidelines (e.g., QbD principles).
• Excellent literature search capabilities coupled with analytical thinking and problem-solving skills
• Excellent teamwork and cross-functional communication abilities.