External Supply – Manufacturing Support - Manufacturing Process Owner - Inspection/Pack

The External Supply - Manufacturing Support Process Owner role is a key role in the newly formed Manufacturing support team requiring in-depth technical and operational knowledge of key capabilities in our external network.

Requirements

• Provide day-to-day operational oversight to ensure execution excellence via successful batch execution and on-time delivery of product.
• Lead and/or support manufacturing/ops readiness
• Supporting manufacturing in delivering supply to patients through Ownership of the assigned processes and taking a proactive approach to safety, quality and compliance
• Subject Matter Expert with thorough in-depth knowledge of the assigned processes and interfaces, ensuring audit and inspection readiness
• Monitor campaign progress and production schedules, identifying and addressing risks
• Track operational performance such as yield, cycle time, and right-first-time metrics
• Accountable point of contact for knowledge of CDMO process documentation (eg SOPs, Training, Electronic Batch Records, Risk Assessments) in assigned area of responsibility
• Gatekeeper (develop, review and update) of changes to CDMO process documentation to maintain structure and control over generation and revision
• Lead and/or Support investigations that impact on safety, quality and/or compliance of the processes, ensuring thorough investigations are carried out and actionable CAPAs, to prevent future reoccurrence, are identified and implemented within agreed timelines
• Ownership and project management, within agreed timelines, of CAPAs and Change Controls at our CDMOs
• Utilises subject matter expertise to identify and lead continuous improvement projects in assigned area of responsibility
• Engaging with staff members to ensure understanding of the processes and working collaboratively cross functionally with Manufacturing, Quality, PD and Supply Chain internally and with CDMOs
• Involved in the daily business management systems and reporting, having a clear understanding of what is happening in the assigned area of responsibility
• Monitor any process trends, including business performance metrics
• Identify actions that will enable the process and the CDMO’s Manufacturing areas better achieve and surpass metrics in the future
• Provide technical input to the shift teams on challenges that are encountered
• Actively looking at ways to assist in the running of the business and provide support to actions that are related to assigned area of responsibility
• Providing expertise to Project Teams responsible for the introduction of new products and projects, ensuring successful implementation in the CDMO’s manufacturing area
• Collaborate with process and analytical teams to ensure accurate transfer of parameters, process understanding, and control strategies
• Effectively engaging and participating within a Lean culture environment where continuous improvement behaviours are expected, and programs are employed
• Managing and implementing projects that develop lean practices in the manufacturing areas

Benefits

• Competitive salary
• Benefits package
• Opportunities for career growth and development