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:
Minimum Master's Degree in Pharmaceutical Sciences with 8 Years of relevant experience.
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