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