Medical device & packing operations

Biocon Biologics · Bangalore g.p.o., India

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 c GMP-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 c GMP, 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 new product introductions.