JOB DISCRIPTION
Job Responsibilities: Deputy / Assistant Manager - Vaccine R&D; (Downstream Process Development)
- Plan, execute, and supervise laboratory-scale, pilot-scale, and process development activities related to downstream processing (DSP) of bacterial, recombinant, and viral vaccine candidates.
- Design and optimize purification processes involving filtration, chromatography, ultrafiltration/diafiltration (UF/DF), conjugation, inactivation, and formulation to achieve target product quality and yield.
- Analyze experimental data, interpret results, and provide scientific recommendations to support process development, process optimization, and troubleshooting activities.
- Lead technology transfer and process scale-up activities from research and development to pilot and commercial manufacturing while ensuring process robustness and reproducibility.
- Coordinate effectively with cross-functional teams including Upstream Process Development, Analytical Development, Formulation Development, Quality Assurance, Quality Control, Manufacturing, Regulatory Affairs,



and Supply Chain to ensure timely project execution.
- Prepare and review technical documents including development reports, process development reports (PDRs), risk assessments, protocols, and technical presentations for internal and external stakeholders.
- Support regulatory submissions by preparing scientific justifications, CMC documentation, dossier sections, responses to regulatory queries, and process-related data packages.
- Drive implementation of Quality Management System (QMS) requirements, ensuring compliance with applicable GMP, GLP, regulatory guidelines, and company procedures.
- Review and approve SOPs, BMRs, protocols, reports, change controls, deviations, CAPAs, risk assessments, and other quality documents related to process development activities.
- Ensure availability of raw materials, consumables, resins, chemicals, standards, and reagents required for uninterrupted execution of de

📌 Deputy Manager-Vaccine R&D-Downstream Process Development (Odhav)
🏢 Zydus Group
📍 Odhav