Research Associate - PDL OSD

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

• Strong 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.