Digitization of regulatory authoring lead for Digital CMC. Responsible for strategy definition, project scoping, development, and deployment of solutions to accelerate the authoring filing sections for all modalities through the use of digital tools.

Part of multiple multidisciplinary teams responsible for development, scale-up, preparation of regulatory filings and validation of numerous cutting edge, life-saving medications. Led efforts to introduce innovative approaches to development, including modeling, simulation and continuous processing. Additional highlights include:• Leading technology transfer of multiple spray drying processes through development, clinical demonstration and validation, to mimic product performance within the filed parameter ranges. Leading a multidisciplinary, worldwide team to review commercial data and production records to improve manufacturing performance and provide the necessary data to support product quality during deviations and excursions. • Modeling and simulation lead for process development to accelerate product development without sacrificing process knowledge. Managing rapid turnaround and multi-year external collaborations (upwards of $1MM) and collating internal model capabilities to increase utility and drive business benefit.• Mentoring junior colleagues to learn new skills and develop knowledge on various unit operations.

• Led a multidisciplinary team in the validation of a process to fill Wurster granulation into sachets. Organized and led meetings across sites to discuss and plan product commercialization activities, including clinical deliveries, commercial launch, continuous process validation (CPV) and lessons learned. • Responsible for drafting and submitting data-rich regulatory filings and responses for successful regulatory applications, challenging fundamental company positions and defining new approaches for development. • Wrote and executed multiple development protocols in a rapid manner to identify and quantify segregation, leading to a robust control strategy that resulted in a successful process validation.• Demonstrated the potential of continuous processing to mitigate segregation for a fixed dose combination. • Assisted with the internal strategy for pediatric product development between minitablets, sachets, liquids and other.

Acted as Project Manager to characterize powder, paste and slurry processing operations through experimentation and finite and discrete element method modeling to develop better models to reduce start-up costs associated with such operations.

Sharing time between the Centre of Material and Process Synthesis (COMPS) at The University of the Witwatersrand in Johannesburg, South Africa and Rutgers University, conducting collaborative research related to particle technology and sustainable energy engineering.• Investigating the effect of particle size on various mineral processes, including coal combustion, platinum group metals extraction and gold extraction, challenging the accepted design parameters for desired particle size. • Implementing COMPS process synthesis approach to identify joint feed energy processes with reduced emissions and developing educational materials to publicize the effectiveness of such an approach.• Exploring the potential of biodigesters to generate biogas for electricity production in rural areas.

• Characterized batch ball milling, finding optimal conditions to produce a product of intermediate size. • Utilized the Attainable Region to optimize batch ball milling, reducing mill processing time by up to 50%.• Implemented model to numerically simulate breakage as a function of impact energy and operating conditions.• Validated mill experiments showing macroscopic flow determines microscopic breakage, in a non-linear way.• Reduced the rate of segregation of granular mixtures of varying size, validating numerical results in the lab.• Mentored 7 students conducting award winning international independent research.

• Increased awareness for the potential application of the Attainable Region in traditional chemical engineering problems, as well as extensions to other applications, including particle technology.• Led technology transfer efforts from SA to NJ to demonstrate the applicability of the AR to optimize milling.

Aided the Commercial Technology group with implementation of new technologies for cryogenic milling of Vitamin C, installed physical components for data acquisition software and performed Haz-Op reviews of the installed unit.

Performed scale reactions to produce testing quantities of promising compounds at the Medicinal Chemistry Prep Lab.