Research Scientist - Formulation Development

About This Role

This research scientist role focuses on the development and optimization of pharmaceutical formulations. It involves understanding new processes and technologies, ensuring quality by design, and providing technical support for manufacturing and new product launches.

Responsibilities

• Participate in the development phase to understand the process/technology
• Ensure process optimization and finalization of critical process parameters with QbD/DOE concept
• Provide technical inputs for preparation of batch manufacturing documents (BMR/Protocol/Sampling plan)
• Prepare scale-up reports and provide relevant recommendations
• Review process qualification reports and provide relevant recommendations
• Perform gap analysis (technical) and provide technical support for site transfers/new launch products
• Provide technical support for process improvement projects and troubleshooting
• Handle OOS/OOT/Deviation during execution/new launch products
• Impart training on new products through tech transfer presentations to cross-functional departments
• Identify and support the introduction of new technologies and equipment (e.g., manufacturing equipment)

Requirements

• Experience in formulation development in reputed pharma organizations
• Exposure to tablets, capsules, pellets dosage forms for regulatory markets (US/EU)
• Thorough knowledge of exhibit and validation philosophy and scientific evaluation methodology
• Process development skills and handling of equipment ensuring safety principles
• Hands-on experience with equipment and planning of exhibit batches
• Strong technical presentation skills
• Good communication and problem-solving skills
• Assertive, proactive, and self-driven
• Sound knowledge of quality management systems