Amgen Hiring For Senior Associate (NPI) Manufacturing at Dublin, County Dublin Full Time

Job Summary:
Operations Lead will serve as primary production process owner responsible for New Product Introduction and Life Cycle Management 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 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.

Primary 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 and approve Bills of Materials
• Develop, review and update Product Quality Risk Assessments

Knowledge/Skills:

• Strong Project Management and organizational 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.
• 2+ 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.

Join Us

If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney diseases, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.