Head - Manufacturing Operations

1. Job Purpose:

Head Manufacturing operation will be responsible for leading the overall manufacturing and operations function of the Medical equipment/ IVD/lifescience business, ensuring capacity, quality, cost, productivity, regulatory compliance, supply reliability and operational excellence.

The role will oversee end-to-end manufacturing operations covering raw-material planning, production, formulation, filling, packaging, quality systems, engineering, maintenance, warehouse, supply chain and plant operations, while ensuring compliance with applicable lifesciences IVD/medical-device regulatory requirements.

Person will work closely with the CEO/MD, R&D, Quality, Regulatory, Sales & Marketing, Finance and Supply Chain teams to scale the organization and build a high-quality, cost-efficient and globally compliant manufacturing operation.

2. Key Responsibilities:

A. Manufacturing & Plant Operations:

- Lead overall manufacturing operations for Healthcare and diagnostic products.

- Drive production planning and execution in line with business demand and sales forecasts.

- Ensure achievement of production targets, OTIF delivery, yield and productivity.

- Develop manufacturing capacity plans for current and future business requirements.

- Optimize manpower, machines, production lines and facility utilization.

- Establish standardized manufacturing processes and SOPs.

- Drive reduction in production cycle time, rejection, wastage and batch failures.

- Ensure robust batch manufacturing, filling, labeling and packaging processes.

- Develop scalable manufacturing systems for new product launches.

B. Quality & Regulatory Compliance:

- Ensure manufacturing operations comply with applicable life sciences, IVD, medical-device, GMP and quality-system requirements.

- Work closely with QA/QC and Regulatory Affairs to maintain audit readiness.

- Ensure effective implementation of SOPs, CAPA, deviation, change control and batch-release systems.

- Drive compliance with applicable standards such as ISO 13485 and relevant Indian/international IVD/lifesciences/medical equipment regulatory requirements.

- Ensure traceability of raw materials, components, batches and finished products.

- Establish a strong quality culture across manufacturing operations.

- Support regulatory inspections and customer audits.

C. Production Excellence:

- Establish and monitor KPIs for production efficiency.

- Drive Lean Manufacturing, Six Sigma, Kaizen, 5S and TPM initiatives.

- Improve OEE, yield, throughput and first-pass quality.

- Reduce batch-to-batch variation.

- Identify bottlenecks and implement corrective actions.

- Develop visual management and daily production review systems.

- Drive continuous improvement across manufacturing processes.

D. Supply Chain & Procurement:

- Work closely with Procurement and Supply Chain teams to ensure uninterrupted availability of critical IVD/lifesciences/medical equipment raw materials.

- Develop strategic sourcing plans for critical biological, chemical and packaging materials.

- Ensure appropriate inventory levels for critical raw materials and finished goods.

- Identify alternate sources and mitigate supply-chain risks.

- Improve inventory turns and reduce obsolete/slow-moving inventory.

- Collaborate with Purchase for vendor qualification and development.

E. R&D / New Product Transfer:

- Work closely with R&D for new product commercialization and technology transfer.

- Establish robust scale-up and manufacturing processes for new IVD/lifesciences/medical equipment products.

- Ensure successful transfer from laboratory/pilot scale to commercial manufacturing.

- Participate in process validation and equipment/facility qualification.

- Ensure manufacturability, cost optimization and scalability of new products.

- Support launch planning and commercialization timelines.

F. Engineering & Maintenance:

- Ensure high availability and reliability of manufacturing equipment.

- Develop preventive and predictive maintenance systems.

- Oversee utilities, HVAC, cleanrooms, water systems and critical manufacturing infrastructure.

- Drive automation and digitization of manufacturing processes.

- Evaluate and implement new technologies to improve productivity and quality.

- Develop CAPEX plans based on business growth and capacity requirements.

G. Cost & P&L Management:

- Take ownership of manufacturing cost and operational efficiency.

- Drive reduction in conversion cost and manufacturing overheads.

- Optimize manpower and resource utilization.

- Prepare and manage annual manufacturing budgets and CAPEX.

- Monitor cost per batch/unit and identify cost-reduction opportunities.

- Support overall business profitability and EBITDA improvement.

H. People & Leadership:

- Build and lead a high-performance manufacturing organization.

- Develop Plant Heads, Production Heads, Quality, Engineering and Supply Chain leaders.

- Establish clear KRAs, KPIs and performance-management systems.

- Develop technical and leadership capabilities within the operations team.

- Build a culture of accountability, quality and continuous improvement.

- Ensure succession planning for critical operational positions