Responsible for formulation and process development of oral immediate-release dosage forms, including oral film and tablet formulations.
Troubleshoot and problem - solve , unresolved or new formula issues.
Design and execute formulation trials, analytical testing 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.
Responsible for all formulation/ process related CMC documents which will be part of regulatory filings.
Write/review master formulas, manufacturing procedures, SOPs, stability protocols/ reports, process validation protocols/reports, Product Development Reports, QOS, QbR etc.
Preparing pharmaceutical development reports, manufacturing formula records (MFRs), Tech transfer, SOPs, guidelines for all processes, documentation and process validation and coordination with production for validation batches
Support technology transfer for manufacturing processes from laboratory scale to production scale.
Supervising material management in F&D
Work with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control etc. to expedite the development and approval of new products by FDA.
Pedigree
3-5 years of relevant work experience in R&D Formulation Development Department
