Deputy/Assistant Manager-Downstream-Process Development for Vaccine R&D

Zydus Group; Ahmedabad District; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Zydus Lifesciences in Ahmedabad, India, is seeking a Deputy/Assistant Manager for Downstream Process Development in Vaccine R&D. You will plan and supervise DSP activities across lab, pilot, and manufacturing scales, optimizing purification steps to deliver high-quality vaccine candidates.

The role involves driving technology transfer, interacting with QA/QC, regulatory, manufacturing, and supply chain teams, and contributing to regulatory submissions and process improvements.

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, UF/DF, conjugation, inactivation, and formulation to achieve target product quality and yield.
• Lead technology transfer and process scale-up activities from research and development to pilot and commercial manufacturing while ensuring robustness and reproducibility.
• Coordinate with cross-functional teams including Upstream Process Development, Analytical Development, Formulation Development, QA, QC, Manufacturing, Regulatory Affairs, and Supply Chain.
• Prepare and review technical documents including 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 QMS requirements, ensuring compliance with 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 for uninterrupted 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 EHS policies, promoting a safety culture and 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.
• Train, mentor, and supervise scientific staff and junior team members, ensuring competency development and knowledge sharing.
• 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.

Job description

Deputy/Assistant Manager-Downstream-Process Development for Vaccine R&D VTC R&D R&d - Ptc Ahmedabad|vtc-ahmedabad, Ahmedabad, Gujarat, India 9 - 15 Years

Job Description

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 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.

At Zydus Lifesciences, w e nurture a culture of innovation, excellence, and inclusivity , driving meaningful advancement in the pharmaceutical and healthcare industries. Fueled by creativity , we constantly exploring new ways to improve patient care and expand healthcare accessibility.

Our commitment to a positive and empowering work environment has earned us recognition as one of India's Best Workplaces in Biotechnology & Pharmaceuticals.