Lead Development of a Drug-Device Combination Product for Smoking Cessation• Pharmaceutical R&D lead - oversee the daily management of the internal team and external contract teams• Led the development of early prototypes and execution of non-clinical and Phase 1 studies to successfully achieve the target drug delivery profile. • Developed CMC strategy and lead for development of a novel drug-device transdermal combination product through clinical development, including completion of non-clinical, Phase 1 and 2 studies under an IND.• Led primary drug container materials selection - liquid fill in a coated polymer container with an elastomeric seal• Supported manufacture and led analytical testing (method development and validation) of product lots for Phase 2 Clinical Studies at selected CMO• Led CMO selection and Tech Transfer for Phase 3 and Commercial Manufacturing and Analytical Test Methods• Packaging lead (design and manufacture) for commercial drug product• CMC lead on the Chrono team in face-to-face meeting with US and several EU regulatory bodies to discuss clinical and regulatory path for approval• Develop a global strategy for evaluation of product stability from the clinic through commercial distribution • Subject matter expert for all drug product aspects including formulation, and material selection

Late Stage Development and Filing of a drug device combination product for iontophoretic transdermal delivery of fentanyl (IONSYSTM) which was approved in April 2015. • Change Control management from a materials, formulation perspective to map late stage development of IONSYS at Incline - acquired by The Medicines Company• sNDA and MAA filed in 2014 with regulatory approval both in the US and EU obtained in 2015• Oversee tech transfer at several CMO and associated laboratories for drug product and combination product manufacturing, lot release (both incoming components and finished product) testing• Lead accelerated aging and stability program (RSL) in both the US and EU to support shelf life of both device and drug product • Conduct biocompatibility and extractables testing for materials in conjunction with an external lab• Establish validated test methods for incoming testing, lot release and stability testing of components, drug product and device components• Design and develop packaging concepts for drug product primary container• Support Quality team in Supplier Audits• Authored CMC sections in the NDA and MAA regulatory dossiers

Incline was acquired by The Medicines Company.

Support Early and Late Stage Development of Drug Device Combination Products• Late stage development of IONSYS included defining material specifications, bicompatilibility testing, stability testing, design verification testing, author CMC sections for regulatory filings • Early stage development included development and scale up of hydrogel and associated electrode formulation for next generation iontophoretic device

• Maintain an excellent working & theoretical knowledge of surfactants, lipids, proteins/peptides, polymers and their chemistries • Modified lung surfactant formulation with improved physical properties for obtaining higher aerosol output rates (for asthma applications) without impacting drug activity• Developed a formulation that could be terminally sterilized by autoclaving • Developed new formulations with increased thermal stability• Pre-formulation and formulation of NCE’s including proteins, peptides and small molecules • Solubility studies for API’s • DOE for selection and optimization of a formulation starting with 150+ combinations that showed desirable properties such as higher aerosol output rates and superior thermal stability• Set up formulation stability programs per ICH guidelines to support pre-IND and clinical studies• Developed and validated stability indicating HPLC methods per ICH guidelines for a variety of peptides, proteins, excipients, and small molecules to support Phase 1 and animal studies. • Optimized existing HPLC API methods in a lipid suspension to result in a higher sample throughput • Implemented new analytical techniques such as moisture determination, particle size distribution (liquid dispersions and aerosols), surface charge, residual solvent measurements, thermal characterization, rheological measurements, ELISA• Key member of the process development team for development and optimization of the key parameters of a lyophilization cycle for a liquid drug product (for both aqueous and solvent based systems)• Developed a standardized method for preparation of lipid based formulations in the lab and scale up for multiple drug evaluations• As Group Leader, responsibilities included validation of all analytical data generated and routine maintenance of instruments in the laboratory