Key Responsibilities :

• Responsible for the development of new products and optimization of existing formulas; product lines including solid dosage products (tablets, capsules) and other delivery forms (eg, liquids, powders) for regulated markets like US, Europe and ROW.
• Responsible for formulation and process development of oral dosage forms, including oral solid and liquid formulations. Troubleshooting and problem-solving of unresolved or new formula issues.
• Design and execute formulation trials and evaluate stability data to finalize formulation composition.
• Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large-scale batches.
• Write / review master formulas, manufacturing procedures, SOPs, stability protocols / reports, process validation protocols / reports, Product Development Reports, QOS, etc.
• Works with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc. to expedite the development and 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-regulated markets like the US, Europe, and ROW.

Required Educational Qualification and Relevant Experience :