Experience from major pharma industries in Non-oral Products: Topical product and transdermal product.      Experience in end-to-end topical product development activities for generic product development ANDA (Cream, ointment, gel, solution, lotion, foam, patch etc.) as well as NDA 505(b)(2), 505(b)(1).     Experience in execution of lab scale manufacturing, reverse engineering, analytical know-how, plant level manufacturing activities; scale-up and exhibit batches based on quality principles QbD, QTPP, CQA, CMA, CPP, RA, FMEA.   Experienced scientist to perform experiments for development of optimum prototypes (generic, non-infringing composition and robust manufacturing process) with diverse class of drugs & prodrugs (sensitive to pH, acid, base, temperature, oxygen, humidity). Experience in regulatory documentation CMC, MF, BMR, PDR, controlled correspondence for CMC, Biowaiver & Dossier preparation for US-FDA, EU-EMA, AU-TGA & DCGI through successful filing.       Experience in working with cross-functional teams (ADD, MSTG, production, QC, QA, RA, IPC, PMO, BD, Microbiology, Pharmacology etc.) to achieve project goals - Filings and subsequent approvals. Knowledge and develop continuous understanding on competitive intelligence, due diligence, US-FDA quality concepts, statistics and global pharma trend analysis to support new product evaluation & introduction.

 

Job Responsibilities: 

 

To design, conduct and verify/review experiments to develop a robust formulation. To do literature search, patent search, prepare summary report and review. To prepare product development reports and protocols. To do product scale-up, exhibit batches and prepare reports for product filing and regulatory queries including post filling and post approval market queries. To prepare documents (i.e. PDR, CPD etc.) for regulatory submission Group work co-ordination. Project status report preparation. Experimental result review, interpretation and conclusion. To prepare technology transfer documents. To procure raw materials (API / excipients), packaging materials, innovator samples in consultation with packaging/purchase department. To do product validation, site transfer/change activities of products. To write Laboratory Notebook to enter details related to drug product manufacturing. To prepare test request for analysis of raw materials (API/Excipients) and Drug product.