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

External Supply – Manufacturing Support - Manufacturing Process Owner

Job Summary:

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.

Primary responsibilities:

• 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 by actively seek opportunities to remove error traps.

• 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 ensuring the documents clearly and correctly direct the process. 

• 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.  Ensuring project timelines are met, challenges identified, mitigations are in place and communication plans delivered to all stakeholders.

• 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. The role will require incorporation of Lean concepts into assigned project(s). Managing and implementing projects that develop lean practices in the manufacturing areas.

Competencies/Skills:

• Ability to travel to sites in our CDMO network and ability to work successfully in a highly international environment

• Problem solving skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity

• Project Management and organizational skills, including ability to follow assignments through to completion.

• Demonstrated ability to work independently and deliver right first-time results under minimal direction.

• Escalate issues professionally and in a timely manner.

• Negotiation and Influencing skills.

• Take initiative to identify and drive improvements using lean six sigma tools.

• Excellent verbal and written communication skills: Strong Technical writing skills for cGxP documentation (eg investigations, procedures, change controls) and good Presentation skills.

• Decision Making skills and confidence to challenge others on decisions that impact the manufacturing area.

• Teamwork and ability to coach, mentor and/or cross train colleagues within core technical areas.

• Ensures compliance within regulatory environment.

• Familiar with data analytics.

Education and Relevant Experience:

• 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.