Harish Gunda
Deputy Manager at Azurity Pharmaceuticals
- Role
- Deputy Manager at Azurity Pharmaceuticals
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Harish Gunda
Formulation Development Scientist with extensive experience in pharmaceutical R&D…
Experience
Deputy Manager
Sep 2023 — Present · Hyderabad, IN
Development of differentiated formulations for regulated markets.• Formulation of Differentiated Products for Liquid and Solid Oral Potentials (Soft Gel Capsules, Oral Solutions). • Initiate Trail batch and Stability study of new products under development. • Responsible to present and compile results of research that has been conducted and to report all the results and findings to the R&D Manager. • Prepare Registration Dossiers (Pre-IND Meeting Briefing Book, Control Correspondence, Product development report, Biowaiver justification, Comparative dissolution profiling, and reference product characterization) for the developed stable formulations.• Sourcing and Material qualification of new raw materials and packaging materials for assigned projects. • Participate in multi-disciplinary product development teams to provide manufacturing process input.• Conduct technology transfer from R&D and CDMO Site to manufacturing facilities and between manufacturing facilities based on sound laboratory/pilot scale studies and a thorough understanding of commercial-scale processes. • Ensure compliance with cGMP and GLP. • Planning and coordination with CFTs, CROs & CMO within India and overseas to ensure flawless functioning and on-time delivery of projects. • Well-versed in Literature Search for products with FDA Orange book, PubMed, Science Direct, EMEA Assessment report, Daily Med, and Formulation Diary.• Preparation of PDR which includes the documents like Strategy Design, QTPP, CQA, CMA-API, CMA • Excipients, CPP, formulation and process optimization, Risk assessment at each stage and other plant related documents like Elemental impurities report, Photo stability report, CDP, BMR, PVP, Hold time study, in-use, stability protocols and reports.
Education
Jawaharlal Nehru Technological University
Master's degree
2013 — 2015
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.