Associate Director, Manufacturing Support (Ms&T Equivalent)
CurrentLead a team of Tech Transfer Leads and Engineers responsible for the Technical Transfer Activities of early phase molecules from Process Development to the Clinical Manufacturing spaceImplement, adhere, and achieve project goals throughout proactive Project Management, Process Modeling, Raw Material projection planning, Scale up and Tech Transfers of assets into the GMP Clinical Manufacturing SpaceTechnology Transfer Team Lead • Oversee planning and execution of manufacturing Tech Transfer projects from early process development to full-scale GMP manufacturing (Downstream and Upstream)• Actively engage in cross-functional relationships to facilitate project planning and project execution• Assure end to end project scope transparency- from project planning to project monitoring and closure• Support CMC authorship, IND applications and amendments• Apply effective risk assessment process to evaluate batch to batch performance, monitor and trend data for detection of potential nonconformities• Provide end -to -end manufacturing process expertise (from Process Development to full scale manufacturing of the final product) to ensure compliance standards are met Global Deviation Investigation Program Lead• Successfully identify project risks and develop mitigation strategies to minimize and monitor product/process impact• Responsible for establishing Risk Assessment, Root Cause Analysis, Product Impact Assessment, • Global Deviation Investigation Program Coach for the Manufacturing and Analytical Department Lead Investigators and Quality Lead Coordinators• Oversee process and product related change controls• Represent the Hopewell Clinical Manufacturing space during Global Quality Audits• Provide support with Health Authorities requests• Supported start up activities for building the HPW manufacturing model from design to production• Led validation activities for the GMP Manufacturing suite to assure site readiness and adherence to quality requirements
