Job Description (JD) - Sr. Manager/Manager, Drug Product (Vaccines):
Position Title:
Manager - Drug Product (Vaccines)

Department:
Manufacturing / Production / Vaccine Operations

Location:
VTC, Zydus Biotech Park, Ahmedabad

Reporting To:
Head - Manufacturing / Senior Manager - Vaccine Operations

Job Summary:
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.

Key Responsibilities:
Manufacturing Operations:
- 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.

Quality & Compliance:
- 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.

Technical & Process Management:
- 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.

Team Leadership:
- Manage and dev

📌 Section Head (Ahmedabad)
🏢 Zydus Group
📍 Ahmedabad