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 protected 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

Job Snapshot

- Updated Date
- 03-08-2026
- Job ID
- JOB10933
- Division
- VTC Mfg - MMR
- Location

R&d; - Ptc Ahmedabad|vtc-ahmedabad, Ahmedabad, Gujarat, India

- Experience
- 15 - 16 Years
- Employee Type
- C-C8-Confirmed-HO Executive

📌 Section Head -mfg-dp (Ahmedabad)
🏢 Zydus Group
📍 Ahmedabad