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. Some international travel will be required to visit contract manufacturing partner sites in Europe.
Responsibilities
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, External Supplier 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 external supplier quality with technical evaluation of NC/CAPA.
Visit contract manufacturing sites to support key production milestones and build relationships.
Basic Qualifications
Knowledge of cGMP’s and other worldwide regulatory requirements.
Proven problem-solving ability.
Excellent oral and written communications skills.
A third level Bachelor’s degree in Science, Engineering or a relevant Quality discipline with 5 years' experience in a similar role OR Master’s degree & 3 years' directly related experience OR Associate’s degree & 10 years of directly related experience.
Full clean driving license required to facilitate travel.
Preferred Qualifications and Experience
Language skills such as Italian or German would be an advantage.
Masters or PhD in Science or Engineering.
5+ years of 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 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.
Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
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