NDDS - (Injectable) Formulation & Development

Role & responsibilities

• Develop injectable dosage forms including:
• Lyophilized injections
• Liquid injections
• Pre-filled syringes (PFS)
• Depot formulations
• Liposomes, microspheres, nanoparticles, and other NDDS-based products
• Conduct pre-formulation studies and compatibility assessments.
• Design and execute formulation trials for new products and lifecycle management projects.
• Optimize formulation composition and manufacturing processes.
• Develop and optimize manufacturing processes for injectable products.
• Scale-up formulations from laboratory to pilot and exhibit batches.
• Support technology transfer to manufacturing sites.
• Investigate formulation and process-related challenges during development and scale-up.
• Coordinate characterization studies including:
• Particle size analysis
• Zeta potential
• Reconstitution studies
• Viscosity measurements
• Stability evaluations
• Prepare and review:
• Protocols and reports
• Development reports
• Technology transfer documents
• Risk assessments
• Stability protocols
• Support dossier preparation for regulated markets such as USFDA, EMA, MHRA, TGA, etc.
• Maintain data integrity and compliance with ALCOA+ principles.

Preferred candidate profile

Educational Qualification

• M. Pharm (Pharmaceutics)
• M.S. (Pharmaceutics)
• M. Tech (Pharmaceutical Technology)