Deputy Manager-Vaccine R&D-Downstream Process Development

Zydus Group; Ahmedabad District; On-site; INR 2,000,000 - 2,800,000; Full time

Job summary

Zydus Group invites a Deputy / Assistant Manager - Vaccine R&D (Downstream Process Development) to lead DSP activities for bacterial, recombinant, and viral vaccine candidates, design purification processes, and optimize filtration, chromatography, and related steps to achieve target product quality and yield.

You will coordinate with Upstream Process Development, Analytical Development, Formulation Development, QA/QC, Manufacturing, Regulatory Affairs, and Supply Chain, prepare development

Responsibilities

• 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

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