Group leader in Process Engineering, Manufacturing Science and Technology. I lead a group of brilliant engineers (chemical, mechanical) that support both clinical and commercial Drug Substance and Drug Product production across multiple production lines.

Group leader in Technology in Drug Substance Manufacturing Science and Technology. I was responsible for a group of engineers that supported clinical and commercial e. Coli and CHO cell culture production.Primary SME (subject matter expert) during multiple audits and inspections. Supported in person discussions with regulators as well as partners and CMO representatives.Responsible for all aspects of registration enabling activities including review and input to process validation strategy and execution, as well as authorship of sections of BLA documents. Prepare strategy for and execute activities in for Product Licensure Inspection (PLI) for multiple molecular entities.

Individual contributor in Drug Substance Manufacturing Science and Technology. Our group of engineers support E. Coli cell culture production. Responsible (as receiver) with process development (donor) for technology transfer from small scale to large-scale bacterial manufacturing process including fermentation, centrifugation, and homogenization. Also responsible for subsequent tech transfer (as donor) to external site (Roche global or CMO) as receiver. This would include everything from the initial facility fit evaluation and process risk revaluation through transfer execution and any technical troubleshooting during the transfer.

Manufacturing Science and Technology (MSAT), Production Technology Group supporting bacterial cell culture production (tech transfer, commercialization, NPI to PAI).

Primarily responsible for shop floor control of large scale drug substance (CHO/e. coli) cell culture operations including scale-up to 12K, homogenization, centrifuge and tangential flow filtration units.Scheduling and process coordination support for a crew of up to twelve technicians in a mission critical environment. Extensive involvement with continuous improvement projects in the areas of quality, safety, and productivity.

Electrical and mechanical troubleshooting technician (CTX, False Color X-Ray, Magnetometers, etc.).