Purpose
This role will require the candidate to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes at ADL. The candidate will establish themselves in a product lead role where the majority of input provided will be leading of process performance qualification (PPQ). In addition, the candidate will be expected to provide technical support to biologics drug product manufacturing at ADL as part of the global Process Development organization. Responsibilities would include the following:
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.
Responsibilities
Requirements
Preferred Qualifications
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Apply For This JobTo apply for this job email your details to brenda.duffy@theaphexgroup.com.
To apply for this job email your details to brenda.duffy@theaphexgroup.com.