The Senior Associate will provide Process Development support primarily to the new formulation processes being introduced in Amgen Dun Laoghaire (ADL), formulation process characterization, qualification of formulation technologies, and implementation of new single-use technologies for new formulation rooms. The role will support large molecule and small molecule drug product manufacturing at ADL as part of the global Process Development organization.
This role will require the candidate to provide support to Capital expansion projects within the scope of the Process development function, contribute with subject matter expertise for Formulation unit operations, and long-term commercial support to Drug product manufacturing.
The candidate will provide technical support to drug product formulation manufacturing at ADL and will contribute as part of the global Process Development organization.
The successful candidate will play a key role in supporting major site expansion initiatives, including formulation process characterization, qualification of formulation technologies, and implementation of new single-use technologies for new formulation rooms.
The role will include support for process performance, technical troubleshooting, process improvement strategies, process validation activities, investigations, and cross-functional technical communication.
New Product Introduction, Lifecycle Management & SME Support
Contribute to product quality assessments, process flow documents, technical assessments, and process control strategies.
Formulation Process Characterization & Technology Implementation
Support formulation process characterization activities, including study design, protocol generation, execution support, data assessment, and technical report authoring.
Support qualification and implementation of formulation technologies for new formulation rooms, including mixing systems, filtration technologies, single-use systems, and other critical formulation equipment.
Support commissioning, qualification, validation, and start-up activities in partnership with Engineering, Validation, Operations, Quality, and external vendors.
Apply scientific and engineering principles to formulation, freeze-thaw, filtration, mixing, processes for parenteral products.
Manufacturing Support & Technical Troubleshooting
Support Process Development activities on the manufacturing line such as engineering runs, characterization studies, and PPQs, including periods of shift support where required.
Process Validation, Risk Assessment & Compliance
Ensure that the site meets customer quality requirements and applicable regulations, including FDA, EU, and international standards.
Investigations, Forensic Lab Support & Continuous Improvement
Leadership, Communication & Cross-Functional Collaboration
