JOB DISCRIPTION

Job Responsibilities: Deputy / Assistant Manager - Vaccine R&D; (Downstream Process Development)

1. Plan, execute, and supervise laboratory-scale, pilot-scale, and process development activities related to downstream processing (DSP) of bacterial, recombinant, and viral vaccine candidates.
2. Design and optimize purification processes involving filtration, chromatography, ultrafiltration/diafiltration (UF/DF), conjugation, inactivation, and formulation to achieve target product quality and yield.
3. Analyze experimental data, interpret results, and provide scientific recommendations to support process development, process optimization, and troubleshooting activities.
4. Lead technology transfer and process scale-up activities from research and development to pilot and commercial manufacturing while ensuring process robustness and reproducibility.
5. 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.
6. Prepare and review technical documents including development reports, process development reports (PDRs), risk assessments, protocols, and technical presentations for internal and external stakeholders.
7. Support regulatory submissions by preparing scientific justifications, CMC documentation, dossier sections, responses to regulatory queries, and process-related data packages.
8. Drive implementation of Quality Management System (QMS) requirements, ensuring compliance with applicable GMP, GLP, regulatory guidelines, and company procedures.
9. Review and approve SOPs, BMRs, protocols, reports, change controls, deviations, CAPAs, risk assessments, and other quality documents related to process development activities.
10. Ensure availability of raw materials, consumables, resins, chemicals, standards, and reagents required for uninterrupted ex

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