• Develop, execute and evaluate engineering studies in support of technology transfer• Scale up lyophilization cycles from pilot scale units to commercial manufacture• Implement technology transfer plans for transfer of lyophilized product• Evaluate innovations and new technologies to drive process improvements • Write technical reports to support the transfer process• Identify critical process parameters based upon process development, experimental evaluation, and historical assessments of manufacturing process• Support pilot scale QbD development activities• Provide technical expertise and support to manufacturing personnel during transfer activities and study execution

Supervised and directed two in-house technicians and contract workers from over 20 vendors.Authored Standard Operating Procedures.Streamlined calibration processes through an intuitive approach to scheduling and executing calibration activities.Assessed instrumentation used in manufacturing and facilities processes such as pure water systems, tangential flow filtration, lyophilization.Initiated and executed engineering change controls.Coordinated calibration and maintenance activities in a dynamic and changing environment.Procured new equipment for department, including an initiative to establish an in-house secondary standards lab.Resolved deviation investigations, including investigation, root cause analysis, and corrective action/preventative action process.Reviewed calibration documentation and managed validated database to schedule and track GMP activities.

Performed pharmaceutical testing under cGMP and GLP conditions, including HPLC, GC, inhalation testing, particle size testing.