Head of Formulation development ( complex products) and process development.

 Responsible for formulation development, ANDA execution, scale-up and commercialization of products in the portfolio under FDA regulated Current Good manufacturing Practices (cGMP) environment. Expertise in Development of Topical products with In-vitro approach and match product profile as Reference product in terms of In vitro release test (IVRT) , In vitro permeation test (IVPT) and Physicochemical test such as a complete flow curve of shear stress (or viscosity) vs. shear rate, linear viscoelastic response, polymorphic form, crystal habit, globule size, pH and Yield stress.  Work closely with other cross functional teams such as Regulatory Affairs, Portfolio, Legal, Analytical R&D, Purchasing and Project Management teams to ensure execution of quality ANDA projects with aggressive timelines to achieve first cycle agency’s approval. Evaluate literature, patents, Design and co-ordinate design around strategy for paragraph IV projects in conjunction with guidance from Intellectual property group. Respond to CMC section of the FDA deficiencies (CR’s and IR’s) on timely manner to meet the product goal date and timely launch of commercial products. Team building activities to ensure team and self are capable of leading the technical role within project timelines. Drives development and tracking ANDA developments with tracking milestones on different phases of projects.

A Formulation Scientist with product development experience in various complex drug delivery systems such as in dermatological dosage forms, Liquid dosage forms, Nasal dosage forms, Rectal Dosage forms, Aseptic,Ophthalmic dosage forms, Powder for suspensions and Resin complex technology. In my career, I have independently developed stable formulations and scale up processes for Semi Solid Dosage forms (Creams, Ointments and gels), Suppositories, Powder for suspensions with Quality by Design (QBD) approach. I was also involved in responding FDA deficiencies within tight timelines, preparation of Product development reports, closely working with contract manufacturing facilities. I have formulated and manufactured lab scale to ANDA scale (Exhibit) batches.

Prepare the company for Aseptic facility, Documentation of Instruments used for aseptic compounding facility.General literature research for specifications on stability and compatibility. Method of compound preparation such as Allegation, Geometric dilution, Aliquot method etc (e.g. pediatric dosage form handbook, facts and comparison, USP etc)