· Leads new product introductions to ADL PM2 and PM3 from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer to PM2 or PM3.
· Be accountable for success of the product transfer project from initiation to the transfer, through line characterisation, engineering studies, process performance qualification and ultimately to regulatory approval.
· Provide solutions when trouble shooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection and transportation for parenteral products through the NPI or post-NPI phases.
· Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. Support commercial drug product manufacturing operations with technical evaluation of Change Control/NC/CAPA and technology transfer.
· The position will report to Process Development Senior Engineer. Moderate international travel might be required during the course of the project.
· Development of validation plans, process performance qualifications for vial and syringe filling.
· Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
· Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer.
· 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 of directly related experience OR Associate's degree & 10 years of directly related experience.
· 5 years' experience in a similar role, (ie in a lead role, decision maker)
· knowledge of cGMPs and other worldwide regulatory requirement.
· Experience with product development, process/product design, develops and characterizes drug product processes etc
· Problem solving ability and excellent oral and written communications skills.
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