Deputy Manager-Vaccine R&D-Downstream Process Development

Zydus Group; Ahmedabad District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Zydus Group is seeking a Deputy/Assistant Manager for Vaccine R&D (Downstream Process Development) to lead downstream processing activities from lab to manufacturing scale. You will design purification schemes, oversee pilot-scale operations, and drive data-driven process optimization.

You will collaborate with upstream, analytical, formulation, QA/QC, regulatory, and supply chain teams to ensure compliant, robust processes and timely project execution across development stages.

Qualifications

• Experience in vaccine R&D or related bioprocess development environments.
• Strong understanding of downstream processing (DSP) including filtration, chromatography, UF/DF.
• Ability to lead tech transfer and scale-up from R&D to manufacturing.
• Familiarity with cGMP, GLP, regulatory guidelines, and QA/QC processes.

Responsibilities

• Plan, execute, and supervise lab- and pilot-scale DSP activities for bacterial, recombinant, and viral vaccine candidates.
• Design and optimize purification processes (filtration, chromatography, UF/DF, conjugation, inactivation, formulation).
• Analyze data, interpret results, and provide scientific recommendations for process development and troubleshooting.
• Lead technology transfer and process scale-up to pilot and commercial manufacturing with robust, repeatable processes.
• Coordinate with Upstream, Analytical, Formulation, QA/QC, Manufacturing, Regulatory, and Supply Chain teams for timely execution.
• Prepare and review development reports, PDRs, risk assessments, protocols, and technical presentations.

Job description

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 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.
• Chromatography and Filtration Technologies
• Viral and Recombinant Vaccine Purification