Job
Description
You will be responsible for the development of new products and optimization of existing formulas in the formulations department. This includes product lines such as solid dosage products (tablets, capsules) and other delivery forms (liquids, powders) for regulated markets like US, Europe, and ROW. Your tasks will involve formulation and process development of oral dosage forms, troubleshooting formula issues, designing and executing formulation trials, and evaluating stability data to finalize composition. It will also be your responsibility to develop manufacturing processes for R&D formulations to ensure successful technical transfer for large-scale batches. Additionally, you will be required to write and review various documentation such as master formulas, manufacturing procedures, SOPs, stability protocols/reports, and process validation protocols/reports. Collaboration with other departments like Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, and Inventory Control will be essential to expedite the development and approval of new products by the FDA. Qualification Required: - Minimum Master's Degree in Pharmaceutical Sciences - 1 year of relevant experience You 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-regulated markets like the US, Europe, and ROW. You will be responsible for the development of new products and optimization of existing formulas in the formulations department. This includes product lines such as solid dosage products (tablets, capsules) and other delivery forms (liquids, powders) for regulated markets like US, Europe, and ROW. Your tasks will involve formulation and process development of oral dosage forms, troubleshooting formula issues, designing and executing formulation trials, and evaluating stability data to finalize composition. It will also be your responsibility to develop manufacturing processes for R&D formulations to ensure successful technical transfer for large-scale batches. Additionally, you will be required to write and review various documentation such as master formulas, manufacturing procedures, SOPs, stability protocols/reports, and process validation protocols/reports. Collaboration with other departments like Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, and Inventory Control will be essential to expedite the development and approval of new products by the FDA. Qualification Required: - Minimum Master's Degree in Pharmaceutical Sciences - 1 year of relevant experience You 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-regulated markets like the US, Europe, and ROW.