Research Associate

7 days ago

Hyderabad, India Aragen Bioscience Full time

Key Responsibilities: Responsible for the development of new products and optimization ofexisting formulas; product lines including solid dosage products (tablets,capsules) and other delivery forms (eg, liquids, powders) for regulated marketslike US, Europe and ROW. Responsible for formulation and process development of oral dosageforms, including oral solid and liquid formulations. Troubleshooting andproblem-solving of unresolved or new formula issues. Design and execute formulation trials and evaluate stability data tofinalize formulation composition. Develop manufacturing processes for R&D formulations so that thetechnical transfer is successful for large-scale batches. Write/review master formulas, manufacturing procedures, SOPs, stabilityprotocols/reports, process validation protocols/reports, Product DevelopmentReports, QOS, etc. Works with Analytical Method Development, Regulatory Affairs, QualityControl, Quality Assurance, Inventory Control, etc. to expedite the developmentand approval of new products by the FDA. Candidate should have hands-on/practical experience in development,technology transfer, and ANDA submissions for solid/ liquid oral dosage forms(solutions, suspensions, tablets, capsules) for regulated and semi-regulatedmarkets like the US, Europe, and ROW. Required Educational Qualification and Relevant Experience: Minimum Master's Degree in Pharmaceutical Sciences with 1 Year relevant experience.

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