★ US Leader for clinical human biophysical studies in the Consumer Health Division:♦ Set up, equipped, ensured qualification and maintained the first human study site for US Consumer Health. ♦ Managed multi-country studies (EU & US), authored clinical protocols, ensured medical governance review, adverse events reporting, volunteer enrollment, informed consents, clinical database registration and reporting. Released clinical supplies at study sites (Master Formulation, Raw Material, Sample Labeling/Blinding, Preservative and Microbiology). Authored final study reports and and study closure. ♦ Managed CMO vendor relationships for raw material supplies, budgeting of vendor work packages and final reporting. Managed of confidential disclosure agreements with legal review. Built strong network of vendor relationships at conferences and meetings to ensure successful service and delivery.

♦ Managed CRO analysts and summer student intern♦ Developed Respiratory Products (MDI/DPI) from Pilot to Commercial Scale for Phase I-IIB, Technology transfer of processes from R&D to Commercial. Manufactured GMP Clinical and Toxicology supplies for dry powder inhaled products.✔ Ventolin MDI, Advair MDI, Advair Diskus, Breo Ellipta♦ Particle Engineered inhalation products for increased aerosol performance♦ Formulated, characterized using solid state tools and/or developed analytical methods for a range of dosage forms post-candidate selection:✔ Pulmonary Controlled Delivery Products✔ Spray Dried Products✔ Inhalation Products (MDI/DPI)✔ Nebulized Products ♦ Set up, qualified and managed an in-vivo Pharmacodynamic modeling assay for sustained-release inhaled products. Designed and engineered equipment and software for in vivo studies. Authored study protocols, executed drug dosing, developed statistical database and authored final study reports.✯ 19 Awards and 1 Honor

♦ Developed analytical methods for antisense oligonucleotide drug products

♦ Manufactured GMP clinical supplies of Metered Dose Inhalers♦ Supervised the administration of radiolabeled MDI at clinical sites for preclinical metabolic and biodistribution studies ♦ Authored drug substance sections of IND applications

♦ Analytical Methods Development of pharmaceuticals encapsulated in multivesicular liposomal formulations, DepoFoam®♦ Developed and validated HPLC methods to quantitate encapsulated API♦ Transferred Analytical Methods to QC

♦ Developed Gas Chromatography Methods♦ Authored Stability Protocols for Commercial Bio-herbicides♦ Developed Analytical methods of Bacillus Thuringiensis fermentation proteins in biopesticide products using SDS-PAGE and HPLC