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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. The Manufacturing Support team will include a variety of roles and will report to the Associate Director of Manufacturing Support. We are currently hiring three of these roles as follows: Role1: Commercial-scale peptide drug substance manufacturing; Role 2: Aseptic DP processes; Formulation, Filling and Lyophilisation; Role 3: Capping, visual inspection and packaging. These roles will support key areas of the business; the Manufacturing Process Owner will direct initiatives that deliver execution excellence in our CDMOs, improve the reliability and efficiency of manufacturing processes in addition to day-to-day support related to unplanned event troubleshooting, investigations, CAPA identification and implementation.
Job Responsibility:
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
Gatekeeper (develop, review and update) of changes to CDMO process documentation
Lead and/or Support investigations that impact on safety, quality and/or compliance of the processes
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
Involved in the daily business management systems and reporting
Provide technical input to the shift teams on challenges that are encountered
Providing expertise to Project Teams responsible for the introduction of new products and projects
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
Requirements:
Minimally Bachelor of Science, Engineering or technical discipline
5+ years of manufacturing experience in relevant Drug Substance, Drug Product Manufacturing or related cGxP manufacturing experience
Experience with regulatory compliance in cGxP manufacturing and in depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products
Ability to travel to sites in our CDMO network and ability to work successfully in a highly international environment
Problem solving skills
Project Management and organizational skills
Demonstrated ability to work independently and deliver right first-time results under minimal direction
Negotiation and Influencing skills
Take initiative to identify and drive improvements using lean six sigma tools
Excellent verbal and written communication skills
Decision Making skills and confidence to challenge others
Teamwork and ability to coach, mentor and/or cross train colleagues
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