• Authoring and resolution of deviations, CAPAs, change controls, and documents in order to meet production and product release requirements• Utilize root cause analysis techniques during the deviation investigational process• Communicate across multiple groups and levels to obtain consensus to facilitate deviation closure• Collaboration with technical writers to write, review, revise and prepare manufacturing documents in accordance with cGMP and regulatory guidelines• Work cross functionally to develop and implement continuous process improvements• Manage multiple priorities independently and as part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization• Accurately communicate progress and updates across multiple levels of the organization and regulatory agencies

• Tasked with providing insight in the reorganization of current operations and project management practices in preparation for company growth and expansion• Perform hands-on management of web development projects in efforts to fully understand the technical aspect of the industry, services provided by the company, and client engagement practices• Introduction of standard operating procedures in order to yield uniform best practices across the team• Provide recommendations on software solutions that maximize internal efficiencies, allow for superior client engagement, and lays the foundation for company growth

• Team leader in the development of dry powder formulations for small molecules, antibiotics, macromolecules, and new chemical entities in support of preclinical through phase I/II trials• Scientific lead in method development efforts supporting technology transfer for phase II programs• Project manager in the development and design of inhaler device aimed at reaching market in 2016• Regular organization, conduction, and presentation at team meetings• Cross-functional leader in matrix organization with daily interactions across multiple project teams• Technical writer of SOPs and investigational study final reports• In-depth awareness of US and EP regulatory guidelines

• Oversight of tissue and viral culture practices for research department focused on models of respiratory disease• Development of novel in-vitro models and assays aimed at understanding molecular pathways behind lead therapeutic mechanism-of-action• Expertise in the investigational study of the following disease states: viral/bacterial infection, Cystic Fibrosis (CF), Idiopathic Pulmonary Fibrosis (IPF), COPD• Coordination of test methods, SOPs, and batch record documentation; composition of invention disclosures and final reports• Key role in the management of data flow and organization• Equipment/supplies purchasing; selection of new technologies for current and future research projects; coordination and tracking of grant budgets

• Coordination of Adenovirus and AAV production and purification• Oversight of tissue and viral culture – scale-up roller bottle culture in antibiotic-free environment• Execution of viral transfections and infections in support of in-vivo research• Upstream and downstream purification methods including HPLC purification (AKTA Purifiers/Unicorn Software) and step & equilibrium gradient techniques• Responsible for execution of cell-based assays and Taqman analysis in the quantification of viral titer