Assist manufacturing technical support, including process trouble-shooting, root cause analysis and investigation on process and/or quality discrepancies and deviations during GMP productions, change controls and CAPAs Support plan and execution of process/product life cycle management, including continuous process improvement to improve robustness/capacity/productivity, and to increase level of safety and/or compliance Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis) SPECIAL JOB REQUIREMENTS . Supports downstream processing unit operations for process implementation, data collection, data analysis, and real time troubleshooting (i.e. chromatography, filtration, TFF, buffer generation, drug product filling).