Manager – Drug Product (Vaccines)
Manufacturing / Production / Vaccine Operations
VTC, Zydus Biotech Park, Ahmedabad
Head – Manufacturing / Senior Manager – Vaccine Operations
The Manager, Drug Product (Vaccines) is responsible for overseeing vaccine drug product manufacturing operations, including formulation, filling, freeze-drying (lyophilization), packaging coordination, process optimization, compliance, and team management. The role ensures product quality, regulatory compliance, operational excellence, and adherence to GMP requirements while meeting production targets.
- Lead end-to-end drug product manufacturing activities for vaccines, including:
- Formulation
- Aseptic processing
- Filling and finishing
- Lyophilization (where applicable)
- Visual inspection and product handling
- Ensure production schedules are achieved safely and efficiently.
- Monitor batch execution and ensure compliance with approved Batch Manufacturing Records (BMRs).
- Drive process improvements to enhance productivity and reduce manufacturing deviations.
- Ensure compliance with cGMP, GLP, GDP, and applicable regulatory requirements.
- Support regulatory inspections, customer audits, and internal audits.
- Review and approve manufacturing documentation, SOPs, change controls, deviations, CAPAs, and risk assessments.
- Ensure data integrity and documentation practices meet regulatory standards.
- Provide technical oversight for vaccine drug product processes.
- Lead technology transfer, scale-up, process validation, and process performance qualification activities.
- Collaborate with QA, QC, Engineering, Validation, and Supply Chain teams.
- Troubleshoot manufacturing issues and implement sustainable solutions.
- Manage and develop production staff, supervisors, and shift teams.
- Conduct performance reviews and identify training needs.
- Foster a culture of safety, quality, compliance, and continuous improvement.
- Drive employee engagement and capability development.
- Ensure adherence to EHS policies and biosafety requirements.
- Promote safe handling of biological materials, chemicals, and manufacturing equipment.
- Lead incident investigations and implement corrective actions.
- Implement Lean Manufacturing, Six Sigma, and operational excellence initiatives.
- Monitor manufacturing KPIs and develop action plans for improvement.
- Optimize resource utilization, batch cycle times, and process efficiency.
- Master's Degree or Bachelor's Degree in:
- Biotechnology
- Microbiology
- Biochemistry
- Pharmacy (B.Pharm/M.Pharm)
- Chemical Engineering
- Life Sciences or related discipline
- 15-20 years of experience in pharmaceutical or vaccine manufacturing.
- Minimum 5-7 years in a leadership or managerial role.
- Experience in aseptic manufacturing and vaccine drug product operations preferred.
- Vaccine manufacturing processes
- Aseptic filling operations
- GMP & regulatory compliance
- Process validation and technology transfer
- Deviation investigation and CAPA management
- Batch documentation review
- Lyophilization processes (preferred)
- Data integrity requirements
- Production planning and scheduling
- Risk management tools
- Leadership and people management
- Strong communication and stakeholder management
- Analytical and problem-solving skills
- Decision-making under pressure
- Project management
- Continuous improvement mindset
- Cross-functional collaboration
- Production plan adherence
- Batch right-first-time rate
- Deviation closure timelines
- CAPA effectiveness
- Audit and inspection outcomes
- Yield improvement
- OEE/Productivity metrics
- Safety compliance metrics
- Training compliance
