Experience - 12–18 years of manufacturing operations experience within Medical Devices, Pharmaceuticals, Biologics, or regulated healthcare manufacturing.

- Significant experience leading assembly and packaging operations.
- Proven experience managing high-performing manufacturing teams in a cGMP-regulated environment.
- Demonstrated success in regulatory inspections and quality systems.
- Strong background in Lean Manufacturing, Operational Excellence, and Continuous Improvement.

Education - Bachelor's degree in engineering.

- Master's degree preferred.

Key Responsibilities Manufacturing Operations Leadership - Lead end-to-end assembly and packaging operations for medical devices, ensuring safe, compliant, and efficient manufacturing.

- Own daily manufacturing performance with complete accountability for delivery commitments, quality, productivity, and cost.
- Drive production planning and execution to ensure optimum utilization of manpower, equipment, materials, and manufacturing capacity.
- Ensure quarterly business deliverables and operational KPIs are consistently achieved.

Delivery

Excellence & Operational Ownership - Take complete ownership for manufacturing schedules and customer delivery commitments.

- Establish and monitor operational KPIs including: o On-Time Delivery o Schedule Adherence o Overall Equipment Effectiveness (OEE)



o Productivity o First Pass Yield o Right First Time o Packaging Efficiency o Training Compliance o Quality Metrics - Proactively identify operational risks and implement mitigation plans to ensure uninterrupted supply. Quality, Compliance & GMP Leadership - Champion a strong quality culture through strict adherence to cGMP, GDP, SOPs, and regulatory requirements.
- Ensure all manufacturing documentation is accurate, complete, and inspection-ready.
- Maintain continuous audit preparedness for internal, customer, and global regulatory inspections.
- Ensure compliance with applicable medical device quality standards and regulatory expectations.
- Promote "Quality First" and "Right First Time" manufacturing practices across the organization.

Process

Excellence & Continuous Improvement - Drive continuous improvement initiatives focused on: o Defect reduction o Cycle time improvement o Cost optimization o Productivity enhancement o Waste elimination o Process standardization - Conduct process capability analysis for development and commercial products.

- Recommend and implement improvements in manufacturing processes, equipment, layouts, and workflows.
- Lead verification and validation activities for process changes where applicable.

Cross Functional

Collaboration - Work closely with: o Engineering & Maintenance o Quality Assurance o Quality Control o Supply Chain o Warehouse o Validation o Regulatory Affairs o Manufacturing Science & Technology (MSAT) - Ensure timely closure of cross-functional actions impacting manufacturing performance.

- Support product transfers, process improvements, equipment qualification, and current product introductions.

📌 Medical Device Packaging Operations Manager (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru