Job Description
Major responsibilities
Plan dual-path development strategies for adherent (cell factories/fixed-bed) and suspension (HEK293-based) processes and assess platformization and scale-up pathways.Define the relationships between critical quality attributes (CQAs) and critical process parameters (CPPs) to establish the upstream control strategy and design space (proven acceptable ranges, PAR), supporting late-stage regulatory filings.Optimize upstream processes (, DNA:PEI ratio, plasmid quantity, cell density, temperature/DO/pH, feeding and medium exchanges, harvest window) and implement robustness-by-design to mitigate inter-batch variability.Develop scale-up strategies, execute engineering runs, and support late-clinical/PPQ readiness.Transfer the process to internal GMP manufacturing or CDMOs, author process development reports, batch records, SOPs, and risk assessments (FMEA).Lead or contribute to quality activities during manufactur...