Job Description: NDDS (Novel Drug Delivery System) Scientist - OSD will be responsible for designing, developing, and optimizing advanced drug delivery systems in oral solid dosage forms such as tablets, capsules, and controlled-release formulations. This role requires expertise in pharmaceutical formulation, process development, and a thorough understanding of regulatory requirements. Formulation Development: Design and develop NDDS formulations for oral solid dosage forms, including immediate release (IR), extended release (ER), and modified release (MR) products. Perform pre-formulation studies, including solubility, stability, and compatibility evaluations. Technology Integration: Implement innovative drug delivery technologies, such as microencapsulation, nano-particle systems, and multi-layer tablets. Optimize drug release profiles to enhance therapeutic efficacy and patient compliance. Process Development: Develop scalable and robust manufacturing processes for oral solid dosage forms. Perform critical parameter optimization for processes like granulation, blending, compression, and coating. Analytical and Stability Studies: Collaborate with the analytical team to develop and validate testing methods for NDDS products. Conduct stability studies in compliance with ICH guidelines. Regulatory Compliance and Documentation: Prepare technical reports, protocols, and batch manufacturing records. Ensure compliance with cGMP, ICH, and FDA guidelines during formulation and process development. Technology Transfer: Oversee the transfer of lab-scale formulations to pilot-scale and commercial manufacturing. Work closely with production, quality assurance, and regulatory teams to ensure seamless transfer. Innovation and Research: Stay updated with emerging trends in NDDS and oral solid dosage technologies. Contribute to patent applications and publications to support organizational innovation initiatives. Key Requirements: M. Pharm / M.S. in Pharmaceutics or related field. 4 to 7 years of relevant experience in formulation development of OSD for USFDA or other regulated markets. Strong knowledge of QbD, scale-up and technology transfer. Experience in developing formulations for bioequivalence studies and regulatory submissions. Familiarity with USFDA/EMEA regulatory guidelines and documentation. Excellent problem-solving, documentation, and communication skills. Preferred Skills: Hands-on experience with granulation, compression, coating, and capsule filling equipment. Ability to work cross-functionally in a fast-paced, deadline-driven environment.
