Fulfills the requirements of managing clinical trials (typically multi-center, multi-national projects) to ensure timely delivery of project required objectives and timelines within the scope of the client agreements for assigned projects and the project budget, with quality. Responsible for the cross-functional team’s compliance with the project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable regulations. Also responsible for the overall execution of the project and may be principal liaison with the client to ensure effective and timely communication of project progress, issues, and plans for resolution of those issues. Work with teams on continuous improvement and process improvement projects focusing on increasing efficiencies and decreasing costs by using lean and SS principles.

Managing and leading new business projects and initiatives to on-time and on-budget commercialization. Improve communication processes to ensure alignment and calibration of involveddepartments; provide leadership to project team enabling successful achievement of project milestones and objectives.

New Product Development and supported launch of OTC, nutritionals and supplements from formulation to large scale manufacture for commercial release. Managing customer requirements, building and sustaining vendor and customer relationships and delivering new product launches with stringent timelines.

Novel Delivery Technologies- with concentration on transdermal and transmucosal platforms. Oral delivery of biologics, transdermal patch systems for biologics and vaccines, siRNA delivery using liposomes. Worked on developing medical device technology and its clinical applications for growth related conditions.

Small molecule early stage cell based toxicology assays.

Small molecule formulation and analytics. Conducted pre-clinical formulation studies for early stage development of small molecules. Performed various LC related analytical studies to assess stability at room temperature conditions.