Headcount is resourcing a Senior Tech Transfer Lead for our multinational client’s biopharma facility in Dublin.
Reporting to the Process Development Senior Engineer, this person will provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes at the client site. The candidate will establish themselves in a product lead role where the majority of input provided will be leading of process performance qualification (PPQ). Lead new product introductions to the site from a Process Development perspective and serve as the Process Development SME for these products following completion of the transfer to the site.
· 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.
· Development of validation plans, process performance qualifications for vial and syringe filling.
· Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones.
· Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations and input to site validation guidance documents.
· Assist in deviation and exception resolution and root cause analysis.
· 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 (i.e. in a lead role, decision maker).
· Knowledge of cGMPs and other worldwide regulatory requirement.
· Ideally possess experience with product development, process/product design, develops and characterizes drug product processes etc
· Highly desirable to possess strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling (PpK / batch homogeneity) and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability.