Position: Lead Medical Device & Packing Operations /n Experience /n /n

- 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 workplace.

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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.

/n /n Education /n /n

- Bachelor's degree in engineering.

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- Master's degree preferred.

/n /n Key Responsibilities /n Manufacturing Operations Leadership /n /n

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

/n /n Delivery Excellence & Operational Ownership /n /n

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

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- Establish and monitor operational KPIs including:

/n /n o On-Time Delivery /n o Schedule Adherence /n o Overall Equipment Effectiveness (OEE)



/n o Productivity /n o First Pass Yield /n o Right First Time /n o Packaging Efficiency /n o Training Compliance /n o Quality Metrics /n • Proactively identify operational risks and implement mitigation plans to ensure uninterrupted supply. /n Quality, Compliance & GMP Leadership /n /n

- 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.

/n /n Process Excellence & Continuous Improvement /n • Drive continuous improvement initiatives focused on: /n o Defect reduction /n o Cycle time improvement /n o Cost optimization /n o Productivity enhancement /n o Waste elimination /n o Process standardization /n /n

- 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.

/n /n Cross Functional Collaboration /n • Work closely with: /n o Engineering & Maintenance /n o Quality Assurance /n o Quality Control /n o Supply Chain /n o Warehouse /n o Validation /n o Regulatory Affairs /n o Manufacturing Science & Technology (MSAT) /n /n

- 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.

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