Role & responsibilities :
- Execute process development activities for tablets, capsules, granules, and coated products.
- Perform process optimization studies for blending, granulation, compression, coating, and encapsulation.
- Conduct scale-up, pilot, exhibit, and validation batches.
- Support technology transfer activities from R&D; to manufacturing sites.
- Investigate process-related issues during development, exhibit, and commercial batches.
- Review batch records, manufacturing instructions, and process-related documentation.
- Prepare development reports, risk assessments, protocols, and technical justifications.
- Analyze process data and identify critical process parameters (CPPs) and critical quality attributes (CQAs).
- Coordinate with Formulation Development, Analytical Development, Manufacturing, QA, QC, Regulatory Affairs, and Engineering teams.
- Support regulatory submissions by providing process development documentation.
- Ensure compliance with cGMP, Data Integrity, GDP, and EHS requirements. Required Technical Skills
- Robust knowledge of OSD manufacturing processes.
- Hands-on experience in:
- Wet Granulation




- Dry Granulation (Roller Compaction)
- Direct Compression
- Compression
- Film Coating
- Capsule Filling
- Knowledge of Process Validation, Technology Transfer, Scale-up, and QbD principles.
- Understanding of equipment such as FBD, RMG, Blender, Compression Machine, Coating Pan, and Capsule Filling Machine.
- Familiarity with statistical tools, DOE, and risk assessment techniques.
- Experience in regulated market products (USFDA, EU, MHRA, ROW) preferred. Preferred candidate profile Desired Competencies
- Process troubleshooting skills
- Analytical and problem-solving ability
- Cross-functional collaboration
- Technical documentation and reporting
- Effective communication and presentation skills
- Project management and execution Experience
- 03 to 06 years of experience in Process Development Laboratory (PDL) for OSD products within a pharmaceutical company.
- Exposure to technology transfer, exhibit batches, scale-up activities, and commercial manufacturing support.

📌 Research Associate (Ahmedabad)
🏢 Intas
📍 Ahmedabad