Downstream-Process Development for Vaccine R&D

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 development activities.
• Manage laboratory inventories and material consumption, ensuring proper stock control, storage conditions, and timely procurement.
• Oversee maintenance, calibration, qualification, and operation of laboratory and pilot-scale equipment in accordance with cGMP and EHS requirements.
• Ensure compliance with Environmental Health and Safety (EHS) policies, promoting a strong safety culture and ensuring safe laboratory practices.
• Lead root cause investigations, troubleshooting activities, and continuous improvement initiatives to enhance process performance, productivity, and product quality.
• Assess and implement new technologies, purification platforms, and process innovations to improve development efficiency and manufacturing capabilities.
• Train, mentor, and supervise scientific staff and junior team members, ensuring competency development, knowledge sharing, and high-performance teamwork.
• Support project planning, resource allocation, and milestone tracking to ensure timely achievement of development objectives.
• Ensure successful execution of vaccine development programs from proof-of-concept through process validation and commercialization stages.