Job Description

Position: Lead Medical Device & Packing Operations

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Experience

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

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• Significant experience leading assembly and packaging operations.

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• Proven experience managing high-performing manufacturing teams in a cGMP-regulated environment.

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• Demonstrated success in regulatory inspections and quality systems.

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• Strong background in Lean Manufacturing, Operational Excellence, and Continuous Improvement.

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Education

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• Bachelor's degree in engineering.

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• Master's degree preferred.

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Key Responsibilities

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Manufacturing Operations Leadership

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• Lead end-to-end assembly and packaging operations for medical devices, ensuring safe, compliant, and productive manufacturing.

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• Own daily manufacturing performance with complete accountability for delivery commitments, quality, productivity, and cost.

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• Drive production planning and execution to ensure optimum utilization of manpower, equipment, materials, and manufacturing capacity.

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• Ensure quarterly business deliverables and operational KPIs are consistently achieved.

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Delivery Excellence & Operational Ownership

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• Take complete ownership for manufacturing schedules and customer delivery commitments.

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• Establish and monitor operational KPIs including:

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o On-Time Delivery

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o Schedule Adherence

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o Overall Equipment Effectiveness (OEE)

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o Productivity

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o First Pass Yield

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o Right First Time

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o Packaging Efficiency

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o Training Compliance

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o Quality Metrics

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• Proactively identify operational risks and implement mitigation plans to ensure uninterrupted supply.

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Quality, Compliance & GMP Leadership

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• Champion a strong quality culture through strict adherence to cGMP, GDP, SOPs, and regulatory requirements.

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• Ensure all manufacturing documentation is accurate, complete, and inspection-ready.

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• Maintain continuous audit preparedness for internal, customer, and global regulatory inspections.

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• Ensure compliance with applicable medical device quality standards and regulatory expectations.

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• Promote "Quality First" and "Right First Time" manufacturing practices across the organization.

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Process Excellence & Continuous Improvement

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• Drive continuous improvement initiatives focused on:

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o Defect reduction

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o Cycle time improvement

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o Cost optimization

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o Productivity enhancement

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o Waste elimination

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o Process standardization

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• Conduct process capability analysis for development and commercial products.

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• Recommend and implement improvements in manufacturing processes, equipment, layouts, and workflows.

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• Lead verification and validation activities for process changes where applicable.

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Cross Functional Collaboration

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• Work closely with:

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o Engineering & Maintenance

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o Quality Assurance

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o Quality Control

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o Supply Chain

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o Warehouse

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o Validation

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o Regulatory Affairs

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o Manufacturing Science & Technology (MSAT)

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• Ensure timely closure of cross-functional actions impacting manufacturing performance.

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• Support product transfers, process improvements, equipment qualification, and new product introductions.

📌 Lead Medical Device & Packing Operations (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru