NDDS - OSD

Role & responsibilities

• Develop MR, SR, CR, DR, pellet and multiarticulate formulations.
• Perform QbD based development and DOE studies.
• Execute scale up, exhibit, validation and commercial batches.
• Support technology transfer activities.
• Prepare development reports, protocols and regulatory documents.
• Coordinate with QA, QC, Production and Regulatory Affairs teams.

Required Skills

• Strong knowledge of NDDS and OSD formulation development.
• Experience in QbD, DOE and statistical evaluation.
• Knowledge of ICH guidelines and cGMP requirements.
• Scientific writing and troubleshooting skills.

Preferred Exposure

• Modified Release Technologies
• Multiarticulate and Palletization
• Hot Melt Extrusion
• Gastro Retentive Systems
• ANDA and Regulatory Filing Support

Preferred candidate profile

• Strong knowledge of NDDS technologies and OSD formulation development.
• Hands-on experience in QbD, DOE, and statistical tools.
• Understanding of cGMP, ICH Guidelines, and regulatory requirements.
• Expertise in tablet, capsule, pellet, and multiarticulate formulations.
• Good analytical, troubleshooting, and scientific writing skills.