Formulation R&D (Sr Manager/AGM)

As a highly skilled Formulation R&D professional, you will be leading the development of oral drug delivery systems, with a primary focus on soft gelatin capsules, tablets, and sachets. Your role will encompass driving end-to-end formulation development, process optimization, and technology transfer from lab to commercial scale. You will be responsible for conceptualizing and executing formulation strategies, troubleshooting technical issues, and ensuring successful product development in alignment with regulatory and GMP standards. Your collaboration with cross-functional teams including analytical R&D, manufacturing, and regulatory affairs will be crucial for innovation and continuous improvement in formulation design. **Key Responsibilities:** - Lead formulation and process development for oral dosage forms including 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:** - Education: B.Pharm / M.Pharm (Pharmaceutical Sciences or related field). - Experience: Minimum 15 years in the pharmaceutical industry, preferably in Formulation R&D. - Proven experience in soft gelatin capsule and tablet formulation development. - Hands-on exposure to ANDA filings and regulatory submissions for regulated markets. - Strong knowledge of GMP guidelines, formulation design, analytical methods, and scale-up processes. - Excellent problem-solving, leadership, communication, and people management skills. - Ability to work on multiple projects with cross-functional teams.,