Formulation Development Lead

We are seeking a highly skilled Formulation R&D professional to lead the development of oral drug delivery systems , primarily focusing on soft gelatin capsules, tablets, and sachets . The role involves driving end-to-end formulation development, process optimization, and technology transfer from lab to commercial scale.

The incumbent will be responsible for conceptualizing and executing formulation strategies, troubleshooting technical issues, and ensuring successful product development aligned with regulatory and GMP standards. The position requires close collaboration with cross-functional teams including analytical R&D, manufacturing, and regulatory affairs, while also contributing to innovation and continuous improvement in formulation design.

Key Responsibilities :

• Lead formulation and process development for oral dosage forms—soft gelatin capsules, tablets, and sachets.
• Plan, design, and execute lab-scale and pilot-scale trials to optimize formulations.
• Troubleshoot and resolve formulation or process-related challenges .
• Drive technical innovation in formulation design and process improvement.
• Develop and evaluate stability studies to finalize product composition.
• Oversee preparation of technical documentation, reports, and batch manufacturing records .
• Support technology transfer activities from R&D to manufacturing (scale-up and validation).
• Ensure compliance with GMP, ICH, and regulatory filing requirements (including ANDA submissions for regulated markets).
• Coordinate with internal and external stakeholders to ensure timely execution of R&D projects .
• Provide technical mentoring and leadership to the formulation development team.

Key Requirements :