Executive- R&D-Formulation & Development

Job Description:

Responsibilities

•  Literature & Pre-Formulation
• Conduct detailed literature reviews to support new product development initiatives.
• Evaluate reference products, patents, regulatory status, and formulation strategies.
• Perform physicochemical characterization of API and excipients (solubility, particle size, hygroscopicity, polymorph).
• Assess API-excipient compatibility, solubility, and stability as part of pre-formulation studies.
•  Formulation & Process Development
• Design and develop robust formulations for tablets and pellets using extrusion-spheronization, layering, and coating (aqueous and non-aqueous).
• Develop tablets via wet / dry granulation or direct compression as per product strategy.
• Optimize process parameters through laboratory and pilot-scale equipment — extruder, spheronizers, FBD, Wurster coater, RMG.
• Apply DoE / QbD principles to identify critical process parameters and critical material attributes.
•  Stability, Validation & Documentation
• Conduct stability studies as per ICH guidelines and internal SOPs.
• Interpret results and recommend necessary formulation or process adjustments.
• Coordinate and execute process validation batches in the production department.
• Prepare and review technology transfer documents — TTD, FDR, protocols.
• Facilitate successful scale-up and handover of developed products to manufacturing.

Qualification & Experience

• Qualification
• B.Pharm / M.Pharm
• Experience
• 3 – 5 years; able to run an area or shift independently (OSD experience preferred).