► Led CMC development from pre-IND into current Phase 3 program for an innovative cardiac imaging agent, driving critical new product towards commercialization and increasing net present value.► Created and edited CMC regulatory submission documents for multiple clinical programs, to assure that CMC issues and documents were never rating limiting for clinical programs. ► Managed the analytical development program- method development, validation, transfer, release and stability testing for all materials supporting clinical programs that assured these elements were one step ahead of the processes they support.► Directed development of formulations, manufacturing processes, qualification of 23 manufacturing sites to support clinical programs, regulatory filings and future commercial production, to assure these functions were done in advance of program needs.► Assured the continuous supply of drug product for clinical trials, through strategic planning and contingencies that facilitated the completion of clinical studies without interruption.

► Led analytical group in the development and validation of methods for API starting materials, intermediates, API and drug product for apadenoson development program, so process support could be provided on schedule.► Served as method validation expert within BMS, leading 8 training sessions at 4 BMS facilities and provided key guidance on the revision of the corporate BMS validation SOP, to resolve a key gap in GMP compliance for the company.► Led initiative to update and revalidate analytical methods for older commercial products that proactively addressed an issue cited by FDA for other companies. ► Provided release and stability testing oversight for Phase 1 to Phase 3 program that assured no disruption in clinical supply and to assure suitability of storage conditions for commercialization.► Directed transfer of API and drug product methods to BMS – Italy manufacturing site that allowed on site release testing and reduced cost of goods.

► Led group in the development of IND formulations for two oncology drugs (one therapeutic, one diagnostic) that allowed product to move forward in clinical trials. ► Led development and validation of methods for API starting materials, intermediates, API and drug product for the oncology program that supported process development and release of clinical materials. ► Led development and validation of methods for phospholipid-based ultrasound contrast agent under tight timeline and company pressure► Drug was licensed in as a Phase 3 clinical program, but methods were at Pre-Phase 1 state.► Improved (more accurate) methods led to critical formulation and manufacturing process changes, and full understanding of product chemistry.► Authored drug product analytical sections of NDA, responded to FDA questions, leading to approval.► Developed improved process for method development and validation linked to clinical phase and customer needs