Executive FRD Non Orals

Roles & Responsibilities
• Design and conduct preformulation and formulation optimization studies for microspheres, implants, in-situ gels, and other complex non-oral dosage forms using QbD approach
• Execute experiments as per Design of Experiments (DoE) methodology
• Perform literature review and prepare scientific summaries for ANDA projects
• Develop product development protocols and prepare regulatory documentation
• Document experimental details in eLNB / METIS systems
• Compile, analyze, and interpret stability data using MINITAB software
• Prepare Technology Transfer (TT) documents, Master Formula (MF), and Risk Assessment documents (CPP & CQA based)
• Draft documentation for Form 29 applications and DCGI submissions
• Manage scale-up activities and exhibit batch execution at plant level
• Prepare stability protocols and comprehensive product development reports
• Conduct risk assessments for elemental impurities, residual solvents, and extractables/leachables
• Support preparation of pre-ANDA meeting packages and scientific justifications
• Develop SOPs and participate in equipment qualification activities
• Coordinate with cross-functional teams including Analytical Development (ADD), Regulatory Affairs (RA), Corporate Quality Assurance (CQA), and Manufacturing Plant

Qualification
• Master of Pharmacy (M.Pharm) (Pharmaceutics / Relevant Specialization Preferred)

Experience
• 1–5 years of experience in Formulation Research & Development (FRD)
• Hands-on experience in microspheres, implants, long-acting injectables, or complex non-oral dosage forms
• Exposure to QbD, DoE, ANDA documentation, regulatory submissions, and stability studies

Skills
• Strong understanding of QbD principles and risk assessment tools
• Experience with DoE and statistical analysis (MINITAB preferred)
• Knowledge of global regulatory requirements (ANDA, DCGI submissions)
• Strong documentation and technical writing skills
• Familiarity with eLNB/METIS documentation systems
• Ability to manage scale-up and technology transfer activities
• Strong analytical and problem-solving skills
• Effective cross-functional coordination and communication abilities

About the Organization
Sun Pharmaceutical Industries Ltd is one of the world’s leading specialty generic pharmaceutical companies with a strong global presence. With advanced R&D capabilities and a focus on complex dosage forms, Sun Pharma offers professionals significant exposure to QbD-driven development, regulatory strategy, and global product lifecycle management.