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 Pdl Osd Ahmedabad (India)
🏢 Intas
📍 India