Career Category

Job Description

Reporting to the Senior Manager of External Process Engineering, this role will be based out of Amgen Dun Laoghaire, Co. Dublin as part of the global Process Development organization. This role will require the candidate to remotely support manufacturing at various aseptic drug product contract manufacturing sites around Europe.

Assignments may include support for new product introductions, lifecycle changes and ongoing commercial production. The candidate may support a broad range of product formats (cartridges, syringes, freeze dried and liquid vials); and a broad range of product types (including monoclonal antibodies, therapeutic proteins, small molecules and more novel modalities), across multiple manufacturing sites.

International travel will be required to visit contract manufacturing partner sites in Europe. The successful candidate will:

• Act as a drug product technical expert, to provide leadership and solutions when troubleshooting parenteral drug product manufacturing, for all processing stages from drug substance thawing, formulation, filling, lyophilisation, inspection, and transportation of vials, syringes and devices, for parenteral products through the new product introduction (NPI) or post-NPI phases.
• Build excellent business relationships with contract manufacturing partners, Global Operations, Contract Manufacturing Quality, and drug product process teams.
• Demonstrate the ability to lead, via cross-site teams, and in general by setting the agenda and identifying potential issues.
• Provide process development expertise for commercial drug product processing in specific areas such as aseptic processing, process characterization, technology transfer, and process validation.
• Troubleshoot issues with drug product processing technologies and equipment.
• Identify and implement operational opportunities for current and new sterile operations.
• Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA.
• Visit contract manufacturing sites to support key production milestones and build relationships.

Basic Qualifications:

• BSc or BE Degree educated with significant relevant experience in contract manufacturing of parenteral dosage forms

Preferred Qualifications and Experience:            

• Masters or PhD in Science or Engineering.
• Significant experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Process Validation.
• Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling, lyophilisation and/or inspection processes.
• Knowledge of development of commercial processes and process characterization.
• Knowledge of protein biochemistry with regard to chemical and physical stability.
• Project management skills including the ability to manage multiple projects and evaluate project resource requirements.

• Strong knowledge of quality and regulatory systems, drug product manufacturing and process validation.
• Proven track record of advancement in an established, high performing organization
• Proven skills in building and maintaining productive relationships with organizational partners such as Manufacturing and Quality Assurance.
• Excellent communication skills able to work with and influence executive management
• Ability to learn and act on dynamic information at a rapid pace