- Development of solid oral formulations (IR/MR tablets, capsules)
- Execution of pre-formulation studies and compatibility studies
- Handling of scale-up, exhibit batch & technology transfer activities
- Preparation of product development reports (PDR), protocols, and documentation
- Coordination with cross-functional teams (QA, QC, Production, Regulatory Affairs)
- Troubleshooting during formulation/process development
- Support for regulatory queries, dossier preparation (ANDA/ROW markets)
- Execution of stability studies and data evaluation
- Ensuring compliance with cGMP, data integrity, and safety practices
- Robust knowledge of OSD formulation development
- Hands-on experience in granulation techniques (Wet/Dry/Direct Compression)
- Experience with equipment: RMG, FBD, Compression machine, Coating pan
- Understanding of QbD concepts, DoE (preferred)
- Knowledge of ICH guidelines, regulatory requirements (USFDA, MHRA, etc.)
- Good analytical and problem-solving skills
Preferred candidate profile
Educational Qualification
- M. Pharm (Pharmaceutics preferred)
Key Deliverables
- Formulation development within defined timelines
- Successful scale-up and tech transfer
- Accurate and compliant documentation
- Regulatory submission readiness
📌 Formulation and Development Scientist - Solid Oral (Ahmedabad)
🏢 Intas
📍 Ahmedabad
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