Senior Associate Manufacturing

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Job Summary:

The Sr. Associate Manufacturing – Strategic Projects role offers the opportunity to collaborate with multiple functions within the Amgen Dun Laoghaire site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility.

The Operations Lead will serve as primary production process owner responsible for New Product Introduction, Life Cycle Management Projects and/or CAPEx projects and 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.

This role is primarily based on-site at Amgen Dun Laoghaire.

Primary Responsibilities:

1. Function as the site interface between the Product Delivery Teams (PDT's), and ADL Manufacturing operations.
2. Engaging with staff members within the Manufacturing department to ensure understanding of the processes and working collaboratively cross-functionally with Facilities & Engineering, Quality, PD and Supply Chain.
3. Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling and Inspection.
4. Develop, review and update Production, Engineering, Operating Procedures & training materials.
5. Assist in providing training on scientific or technical aspects of the current process/project(s) to Direct Manufacturing.
6. Evaluate, plan, and implement solutions for process improvement opportunities both current and project related.
7. 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.
8. Provide troubleshooting support throughout the project and on the floor during execution of activities.
9. Hold people to account for delivery and behaviours within the Manufacturing Support team and associated with the project(s).
10. Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing.
11. Partner with Learning & Performance to define training strategies for current processes, NPIs and complex projects.
12. Consult with Quality Assurance to ensure that GMP standards are maintained in line with current SOP's, batch documentation and licences.
13. Develop, review and update protocols for manufacturing activities.
14. Documentation and approval of protocol deviations for manufacturing activities.
15. Consult with Process Development, Direct manufacturing, Equipment, and System Owners regarding process changes in an effective and timely manner.
16. Own and lead change controls as required by the Manufacturing Support team.
17. Review Bills of Materials.
18. Develop, review and update Product Quality Risk Assessments.

Knowledge/Skills:

1. Strong project management and organisational skills, including ability to follow assignments through to completion.
2. Critical thinking skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity.
3. Negotiation and Influencing skills.
4. Take initiative to identify and drive improvements.
5. Excellent verbal and written communication skills: Strong technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good presentation skills.
6. Escalate issues professionally and in a timely manner.
7. Decision Making skills and confidence to challenge others on decisions that impact the manufacturing area.
8. Teamwork and coaching others.
9. Ensures compliance within regulatory environment.
10. Demonstrated ability to work independently and deliver right first-time results under minimal direction.
11. Bachelor's degree in a science discipline.
12. 5+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry.
13. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.