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 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.

Safety & EHS
- Ensure adherence to EHS policies and biosafety requirements.
- Promote secure handling of biological materials, chemicals, and manufacturing equipment.
- Lead incident investigations and implement corrective actions.

Continuous Improvement
- 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.

Required Qualifications

Education

- Master's Degree or Bachelor's Degree in:

- Biotechnology
- Microbiology
- Biochemistry
- Pharmacy (B.Pharm/M.Pharm)
- Chemical Engineering
- Life Sciences or related discipline

Experience

- 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.

Technical Competencies

- 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

Desired Skills

- 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

Key Performance Indicators (KPIs)
- 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

📌 Section Head -Mfg-DP (Ahmedabad)
🏢 zydus
📍 Ahmedabad