• Providing strategic direction in CMC (technical and operational) for development (early stage through NDA approval) and post commercial programs and products• Support management of contract development and manufacturing organizations• Review and negotiate development agreements, supply agreements and SOWs• Provide CMC regulatory strategy and review of regulatory documents• Review and support technical diligence of IP and products

• Head of CMC responsible for both commercial and product development teams that include formulation development/ process development, analytical development, technical operations, project management, and commercial supply chain functions

• Successfully led and managed cross functional teams on multiple NDA projects at CMOs from development stage through commercialization• CMC lead for projects from clinical stage (Phase I, II, and III batches) through registration and validation / commercialization• Led and managed technology transfer and other projects related to commercial products (API/ excipient/ packaging component changes, changes in batch scale and process improvement) of both solids and semi-solids• Provided scientific and technical leadership for scale-up, process development, formulations development and served as a subject matter expert in the area of semi-solids and liquids

Responsible for technical issues related to manufacturing / packaging of semi-solids and liquid products Led a LEAN deployment on the semi-solids packaging line and improved OEE, reduced change over times, reduced scrap rates and cycle timesProduct development and product transfer from R&D and 3rd party sites. (Solid, Liquid and Semi-solid dosage forms.) Transferred solid dosage form products to Lincoln Site, and the processes included both direct compression and wet granulation solidsConducted process validation, process improvements including PAT (Process analytical technologies) and cleaning process improvements to improve quality, cost and efficiencies of processes Member of Quality Stability Evaluation committee and Raw Material Selection committee. Approved various stability documents including protocols / reports, assessments for raw material changes, FDA stability commitments, filings and registrations in US and other countries (EU, Latin America and Strategic Growth Markets) Provided technical assistance to operations in the area of manufacturing process and equipment (Solid, Liquid and Semi-solid dosage forms)

Provide manufacturing and technical support to commercialized products including Scale-Up of products (suspensions, solutions, lotions) with the use of appropriate process parameters and equipments.Conduct process improvements and investigations for marketed products and recommend changes to process parameters, formulation or equipment in the compounding, filling and packaging of suspensions, solutions and lotions.Prepare and review new batch records and make changes to old batch records.Lead manufacturing of clinical supplies and other large-scale R&D batches of topical products.Co-ordinate and oversee the manufacturing of products for ANDA submissions and manufacturing of validation batches.Assist in providing responses to ANDA deficiencies and in the preparation of CMC section of ANDA submissions.Coordinate and perform organoleptic studies on formulations with marketing department. Responsible for planning, designing and executing Formulation Development leading to ANDA product submissions of oral and topical Liquids.Prepare scientific protocols, methods and component specifications. Responsible for conducting investigations using strong scientific methods.Manage R&D Controlled substances records and inventory controls as per DEA requirements.

Plan, design, perform experiments, investigate results and interpret data towards testing hypothesis of the following:Determination of the effect of drugs & formulations on cell culture models using cell-based assays such as cell viability, cell proliferation, cytotoxicity & nitric oxide assays. Effect of drugs on Protein Expression (including receptors) in cells lines.

Responsible for teaching and evaluating the lab work of second year Pharm D. students in Micro encapsulation, Dissolution, Formulations of creams and tablet coating experiments.