Well versed with Formulation Development, Technology Transfer, Scale Up, ANDA, Quality by Design, FDA/MHRA Query Response, IVIVC, Patents, Patent Cooperation Treaty, Patent prior art search and analytics, ICH Quality Guideline, CTD modules.
Research Associate at R&D (Formulation Development)
IPCA Laboratories Limited
From May 2013
➢ Plan, design and implement DoE for robust product/process development in compliance with regulatory agencies, for ANDA/EU products.
➢ Literature and patent search, analytics, review, scientific discussion and documentation.
➢ Application for Test License, Import License and activities to obtain Product Clearance.
➢ Execution of pre-formulation and trial batches for formulation development.
➢ Preparation and management of stability batches, stability data collection and compilation.
➢ Execution of Demo batches for technology transfer to Location.
➢ Preparation of Master Manufacturing Document (MMD), Bill of Materials (BOM) and Export Purchase Order (EPO)
➢ Product Development Report (PDR) as per Quality by Design approach.
➢ Execution of Optimization and Exhibit batches at Location.
➢ Co-ordination with related departments like marketing, project management, analytical, manufacturing plant and regulatory to accomplish the given project.
Formulation and Preformulation Studies
➢ Proficient in design of experiment (DoE) application and well versed with Quality by Design (QbD) based product & process optimization (Generics product development) as per ICH Q8, Q9 & Q10 guidelines.
➢ Well versed in the development of oral pharmaceutical dosage forms such as Tablets, Capsules and MUPS (Extended and Sustained release) as per project requirement.
➢ Expertise in Coating (Film and Functional coating) by Auto coater system.
➢ Fluidized Bed Processor (Pam Glatt 1.1) Wurster Coating.
➢ Tablet Compression Machines (Fette, Legacy).
➢ Rapid Mixer Granulator.
As a part of curriculum, i have sound knowledge of Regulatory affairs, CTD modules, various software available for eCTD and basic XML language. I worked on novel ophthalmic drug delivery systems, wherein i have developed nanoparticulate delivery system for antiglaucoma drug. Also I have completed a project concerned with formulation of Alendronate Sodium Gel using Carbopol, its rheology, content uniformity, drug release sterilization and packaging aspect for periodontal use.
Qualifications & Certifications
Bombay College of Pharmacy, University of Mumbai
Dr. Babasaheb Ambedkar Marathwada University
Y.B. Chavan College of Pharmacy, Dr. Babasaheb Ambedkar Marathwada University Aurangabad