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Manufacturing Project Manager
1 week ago
The Operations Process Lead plays a pivotal role in collaborating with various functions within the Amgen Dun Laoghaire site, fostering a dynamic environment that encourages growth and development. This position offers the opportunity to gain a profound understanding of manufacturing operations and planning activities within the facility.
The Operations Lead will serve as the primary production process owner responsible for New Product Introduction, Life Cycle Management Projects, and/or CAPEx projects, as well as established process improvements projects. This role requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation, and Capping.
The Operations Process Lead will be the operations point of contact for coordinating the manufacturing effort and driving process efficiencies as part of the project. They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to ensure streamlined manufacturing operations are enabled in both vial and syringe facilities.
This role is primarily based on-site at Amgen Dun Laoghaire.
Primary Responsibilities:
- Function as the site interface between the Product Delivery Teams (PDT's), and ADL Manufacturing operations.
- Engage with staff members within the Manufacturing department to ensure understanding of the processes and work collaboratively cross-functionally with Facilities & Engineering, Quality, PD, and Supply Chain.
- Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling, and Inspection.
- Develop, review, and update Production, Engineering, Operating Procedures & training materials.
- Assist in providing training on scientific or technical aspects of the current process/project(s) to Direct Manufacturing.
- Evaluate, plan, and implement solutions for process improvement opportunities both current and project related.
- Support scheduling and execution of Characterisation, Engineering, and PPQ runs, ensuring all necessary pre-requisites are included on the schedule and assess process performance by observation of floor operations and review of performance data.
- Provide troubleshooting support throughout the project and on the floor during execution of activities.
- Hold people to account for delivery and behaviours within the Manufacturing Support team and associated with the project(s).
- Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing.
- Partner with Learning & Performance to define training strategies for current processes, NPIs, and complex projects.
- Consult with Quality Assurance to ensure that GMP standards are maintained in line with current SOP's, batch documentation, and licences.
- Develop, review, and update protocols for manufacturing activities.
- Documentation and approval of protocol deviations for manufacturing activities.
- Consult with Process Development, Direct manufacturing, Equipment, and System Owners regarding process changes in an effective and timely manner.
- Own and lead change controls as required by the Manufacturing Support team.
- Review Bills of Materials.
- Develop, review, and update Product Quality Risk Assessments.
