L5 To L6 - ADL-Topical

Job Description – Formulation & Development (F&D) – Nasal Products Position: Formulation & Development Scientist – Nasal Dosage Forms Department: Research & Development / F&D Location: Pune (or specify) Key Responsibilities 1. Formulation Development Develop nasal formulations including solutions, suspensions, sprays, gels, and powders. Conduct pre‐formulation studies, solubility profiling, and compatibility evaluations. Design formulation strategies for both new product development and lifecycle management. Optimize formulations for stability, sensory attributes, spray characteristics, and patient usability. 2. Process Development Develop manufacturing processes for nasal formulations and prepare scale-up protocols. Support technology transfer to the production site through documentation, trials, and training. Coordinate with manufacturing and quality teams during exhibit/validation batches. 3. Analytical & Stability Studies Coordinate analytical method development for assay, impurities, particle size, spray pattern, plume geometry, droplet size distribution, and microbiological parameters. Review and interpret stability data as per ICH guidelines and prepare technical reports. 4. Documentation & Regulatory Compliance Prepare master formulas, development reports, justification documents, and technology transfer documents. Ensure compliance with regulatory guidelines (USFDA, EU, WHO, CDSCO, etc.) relevant to nasal dosage forms. Support dossier preparation including QOS, PDR, QbD elements, and risk assessments. 5. Project Management Manage timelines and deliverables for multiple F&D nasal projects. Coordinate with cross-functional teams like Packaging, RA, QA, QC, SCM, and Production. Provide regular project updates to senior management. 6. Innovation & Research Explore advanced nasal drug delivery technologies (mucoadhesive systems, preservatives-free, multidose devices, sustained release). Support evaluation of new excipients, packaging components (pumps, valves, actuators), and device compatibility. Required Skills & Competencies Strong knowledge of nasal delivery systems, spray devices, and regulatory expectations. Good understanding of formulation science, QbD, DoE, and troubleshooting. Hands-on experience with laboratory equipment related to nasal sprays (DPI systems, spray characterization tools). Excellent documentation, communication, and project management skills.