Deputy Manager-Vaccine R&D-Downstream Process Development
Zydus Group
- Location
- Ahmedabad, Gujarat, India
- Job type
- Full-time
Required skills
- compliance
- cross-functional
About the role
Zydus Group
Website:
zyduslife.com
Job details:
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.
Key Competencies
- Vaccine Process Development (DSP)
- Chromatography and Filtration Technologies
- Conjugate Vaccine Development
- Viral and Recombinant Vaccine Purification
- Technology Transfer and Scale-Up
- GMP & Regulatory Compliance
- Data Analysis and Scientific Reporting
- Project and Team Management
- Risk Assessment and Problem Solving
- Cross-Functional Collaboration
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