Amgen Process Development Scientist/Engineer in Dun-Laoghaire-Rathdown, Ireland
Depending on assignments, 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;
Develop as a drug product technical expert, to provide leadership and solutions 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.
Work with contract manufacturing partner SME's, Global Operations, Contract Manufacturing Quality, and drug product process teams.
Work as a member of cross site teams to support contract manufacturers and to identify and resolve 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 improvements 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 observe production operations and build relationships
3 -5 years pharmaceutical manufacturing experience in either a drug product or drug substance manufacturing environment
Knowledge of cGMP's
Proven problem solving ability
Excellent oral and written communications skills
Strong academic results in a third level Bachelor's degree in Science, Engineering or a relevant quality discipline
Full clean driving licence required to facilitate travel
Preferred Qualifications and Experience:
Language skills such as Italian, Russian or German.
Masters or PhD in a Science or Engineering or related discipline
Experience with aseptic drug product processes such as; component preparation (siliconization, autoclaving, depyrogenation), sterile filtration, filter integrity testing, filling, freeze drying, capping, manual and automated visual inspection
Experience with different aseptic drug product presentations, such as pre-filled syringes, cartridges, lyophilised vials and liquid vials
Experience with the quality testing methods and interpretation of results for biological molecules
Aseptic drug product validation experience such as; media fill, sterilisation validation, equipment qualification, process validation
Experience dealing with contract manufacturing organisations
Project management experience
Demonstrated ability to lead and take responsibility.
Amgen is an equal opportunities employer