This is an exciting opportunity responsible for overseeing Manufacturing Sciences & Technology (MS&T) related drug product and fill/finish technology transfer and manufacturing activities for biologics manufacturing. You will be charged with overseeing the following activities:
* Leading MSAT staff and projects relating to drug product manufacturing operations.
* Providing technical leadership and subject matter expertise relating to drug product fill & finish related deviations, change control, process optimization, and technical troubleshooting.
* Handling of complex and highly automated systems and overseeing all state-of-the-art equipment including formulation, aseptic liquid filling, pre-filled syringe lyophilization, and packaging apparatus.
* Working cross functionally with Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments to lead drug product fill & finish related process improvement, process validation, process change control, deviation investigation and process characterization activities.
* Serving as a technical/scientific Subject Matter Expert drug product fill & finish activities.
* Defining, designing and developing critical process capability, critical process parameters, and process performance measurements through multivariate modeling and statistical measurements of Cp, Cpk, Pp, and Ppk.
* Training engineering staff on cGMP compliance and SOPs including writing/reviewing batch records, process validation documents, and sections of regulatory filings.
* Assisting in the build-out of BioPharma Manufacturing Data Systems, Process Intelligence, and Process Monitoring systems.
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