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 setting.
- 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 new product introductions.

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