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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. They will be the operations point of contact for coordination of the manufacturing effort and will be responsible for driving process efficiencies as part of the project for operations. 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.
Job Responsibility:
Function as the site interface between the Product Delivery Teams (PDT’s), and ADL Manufacturing operations
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
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
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
Own and lead change controls as required by the Manufacturing Support team
Review Bills of Materials
Develop, review and update Product Quality Risk Assessments
Requirements:
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
Strong project management and organisational skills
Critical thinking skills
Negotiation and Influencing skills
Excellent verbal and written communication skills
Strong technical writing skills for GMP documentation
Decision Making skills and confidence to challenge others
Teamwork and coaching others
Ensures compliance within regulatory environment
Demonstrated ability to work independently and deliver right first-time results under minimal direction