Career Category

Job Description

Job Posting Title:       Process Development Principal Engineer

GCF Level:                 6

Career Category:        Process Development

Location:                    ADL

Reporting to the Director of Drug Product Process Development, this role will be based out of Amgen Dun Laoghaire, as part of the global Process Development (PD) organization. This role will require the candidate to lead a team which supports manufacturing at various drug product contract manufacturing sites around Europe. The team supports new product introductions, lifecycle changes and ongoing commercial and clinical production and development.

The team supports 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 sites.

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

• Provide technical and management leadership to a cross functional team of engineers and scientists for all processing stages from drug substance thawing, formulation, filling, lyophilization and visual inspection unit operations.
• 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.
• Act as the accountable point contact from PD organization for product/process support for technology transfers and ongoing clinical and commercial drug product manufacturing at assigned contract manufacturing sites.
• Build excellent business relationships with contract manufacturing partners, Global Operations, Contract Manufacturing Quality, and drug product process teams.
• Lead functional and cross functional teams by setting the agenda, identifying issues and driving to goal completions and target dates.
• Troubleshoot issues with drug product processing technologies and equipment.
• Escalate issues, recommendations, and/or unresolved decisions in a professional and timely manner to the appropriate governance.
• Holds others responsible or answerable for their actions, for exemplary job performance, and achieving business results.
• 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
• Strong leadership skills with significant managerial experience directly managing people, teams, projects, and programs

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.
• Ability to lead effectively in an highly matrixed organization
• Strong knowledge of quality and regulatory systems, drug product manufacturing and process validation.
• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
• Full clean driving licence to facilitate travel

Amgen is an equal opportunities employer