Section Head -Mfg-DP

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 safe 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