Formulator

• Literature Search, Design product development strategy using hands on technical knowledge, literature search and risk assessment to have a plan of action with timelines
• Prepare all stage gates documents which include QbD documents (Stage I, II, III), SRM, FRM and ESM slides and development protocol for filling
• Gather data from pre-formulation studies by carrying out characterization of reference product and optimize the formula in order to develop a robust product
• Develop the formula or process of an existing product by carrying out experiments, reviewing historical data and specifications and comparing with the reference product in order to improve quality or reduce the manufacturing time of the existing product
• Plan and indent, Filters, RM and PM required during product development and submission batches
• Prepare manufacturing guideline, FPS, PDCL, PAF, Data sheet, RMCA code request, Test license requirements, mfg. licence communication, DCGI NOC request, TT report preparation and DP
• Compile and assess data generated during the development cycle through review and discussions to study the trend of the product performance and its quality
• Conduct lab batches for Prototype process and formulae development. Prepare stability batches and generate stability data with finalized prototype formulation for submission to the regulatory agency
• Prepare regulatory submission data by conducting R&D trials and executing regulatory submission batches at the unit for successful filing
• Provide deficiency response support by generating data at R&D/Unit required for approval of the product

1-2 year experience in Formulation R&D (Preferably in Injectables)

Master in Pharmacy (Specialization in Pharmaceutics)