Lead Medical Device & Packing Operations

Biocon Biologics; Bengaluru; On-site; INR 4,000,000 - 6,000,000; Full time

Job summary

Biocon Biologics is seeking a Lead Medical Device & Packing Operations to lead end-to-end assembly and packaging of medical devices. The role demands ownership of daily manufacturing performance, quality, and delivery commitments, while driving planning, KPI achievement, and cost controls.

The ideal candidate will have 12–18 years of regulated manufacturing experience, strong Lean and continuous improvement background, and a solid track record in GMP compliance and regulatory readiness.

Qualifications

• Bachelor's degree in engineering is required.
• 12–18 years of manufacturing operations experience in regulated healthcare.
• Experience leading assembly and packing operations in medical devices/pharma.
• Proven ability to manage teams in a cGMP environment.
• Strong focus on quality systems and regulatory inspections.

Responsibilities

• Lead end-to-end assembly and packaging operations for medical devices.
• Own daily manufacturing performance and delivery commitments.
• Drive production planning to optimize manpower, equipment, and materials.
• Ensure operational KPIs are achieved and quality is maintained.

Skills

Lean Manufacturing

Operational Excellence

Continuous Improvement

cGMP Compliance

Regulatory Inspections

Education

Bachelor's degree in engineering

Master's degree preferred

Job description

Position: Lead Medical Device & Packing Operations

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:
  • On-Time Delivery
  • Schedule Adherence
  • Overall Equipment Effectiveness (OEE)
  • Productivity
  • First Pass Yield
  • Right First Time
  • Training Compliance
  • 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:
  • Cycle time improvement
  • Productivity enhancement
• 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:
  • Quality Assurance
  • Quality Control
  • Supply Chain
  • Warehouse
  • Validation
  • Regulatory Affairs
  • 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.