Chosen to develop the global expansion strategy for development and commercial assets.

Chosen to develop the global expansion strategy for development and commercial assets

Responsible for all technical aspects of the commercial external manufacturing network including commercialization of new products and technologies developed internally or in-licensed from other organizations

Selected to manage a team of technical professionals responsible to support commercial production at contract manufacturing facilities. Ensured that projects were executed on schedule and in accordance with company priorities.

Participated in post-approval development activities in support a metered dose inhaler. Prepared post-approval submissions for the use of a modified component and for a new presentation of a metered dose inhaler.

Participated in the formulation development of a metered dose inhaler. Contributed to the Module 3 (chemistry, manufacturing & controls) section of the NDA for a metered dose inhaler (submission approved during the first cycle review at FDA)>. Managed activities at multiple external manufacturing suppliers and contract laboratories simultaneously to meet project needs.

Responsible for the formulation development of dry powder inhalation products and inhalation solutions. Contributed to regulatory submissions as required. Participated in portions of the development of a metered dose inhaler.

Developed dry powder formulations based on Dura's Spiros technology. Drafted Module 3 sections of regulatory submissions for dry powder pulmonary products. Directly supervised scientist, engineers and research associates. Coordinated all aspects of production of clinical supplies for specific projects.

Developed and characterized formulations and components used in pulmonary products (MDIs and DPIs). Completed preformulation characterization of new drug substances formulated in a variety of standard dosage forms.