• Support drug product Process Validation activities, Scale up and post-approval changes (SUPAC) and routine commercial manufacturing at CDMOs. • Identify critical process parameters based on the risk assessment and understanding the impact of material attributes and process parameters on critical quality attributes. Implement appropriate process controls to ensure delivery of consistent batch product quality. • Draft, coordinate, execute validation protocols, perform data analysis, author/review and approve process validation reports with consistent and effective communication with other functions. • Provide support to routine process validation studies, assisting with product technology transfers or lifecycle management changes such as process improvement, addition of secondary API and manufacture site change etc. • Perform technical review of drug product manufacture deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for drug product lot release (assess deviations and process changes). • Work closely with other team members and cross-functionally with quality assurance, analytical/QC, chemical development, supply chain, and project management team to achieve all project deliverables. • Provide support for technical decision-making regarding cGMP compliance, validation strategy and regulatory pathway for SUPAC changes etc. • Familiar with statistical analysis software, such as JMP. • Perform process capability analysis, identify risk, and make recommendations for process improvement. • Manage documentation, change controls, material inventory, product complaints, and deviation resolution at CDMOs. • Represent the drug product group as a Subject Matter Expert to support audits and regulatory inspections. • Support authoring the relevant technical sections of regulatory filings. • Support late-stage validation and post-approval readiness activities and commercial manufacture activities within a virtual working environment.