Senior Research Associate (M.Pharm)

Roles & Responsibilities:
• Develop formulations for Oral Solid and Oral Liquid dosage forms
• Design and develop DR and ER pellet formulations
• Work on platform technologies including Hot Melt Extrusion (HME), Extrusion & Spheronization, solid dispersions, and Wurster techniques
• Handle development of low-dose and potent molecules with appropriate controls
• Prepare and review technology transfer documents including MFR, BOM, Specifications, Stability Protocol & Report, Photostability, Thermal Cycle, In-use and Reconstitution study documents
• Execute technology transfer (TT) activities and support scale-up (SU) and exhibit batch (EB) execution at CMO sites
• Prepare and review regulatory filing documents such as 3.2.P.1, PDR (3.2.P.2) and related sections
• Interpret stability data and provide scientific justification
• Address regulatory queries and provide technical responses
• Review development and transfer reports to ensure compliance and quality

Qualification:
• Master of Pharmacy (M.Pharm) in Pharmaceutics (Mandatory)

Experience:
• Proven experience in formulation development and optimization
• Mandatory experience in DR and ER pellet formulations
• Strong expertise in platform technologies such as Hot Melt Extrusion (HME), Extrusion & Spheronization, and solid dispersion technologies
• 4–6 years of hands-on experience in formulation development of Oral Solid and Oral Liquid dosage forms
• Exposure to technology transfer to CMO sites
• Experience in regulatory documentation and submission support
• Hands-on experience in handling potent and low-dose formulations

Skills:
• Strong scientific knowledge in oral dosage form development
• Expertise in pelletization and modified release technologies
• Good understanding of regulatory filing structure and documentation
• Stability data interpretation and troubleshooting skills
• Strong documentation and report review capabilities
• Cross-functional coordination and problem-solving skills

About the Organization:
Aveva Drug Delivery Systems Inc specializes in advanced drug delivery solutions and pharmaceutical product development. The organization focuses on innovative formulation technologies, regulatory-compliant processes, and seamless technology transfer to deliver high-quality healthcare products to global markets.