Head - Manufacturing - IVD/Medical Devices

About the job:

Job Purpose:

The Head - Manufacturing will be responsible for leading the overall manufacturing and operations function of the IVD 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 IVD/medical-device regulatory requirements.

The Head 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.

Key Responsibilities:

Manufacturing & Plant Operations:

• Lead overall manufacturing operations for medical device/IVD reagents, kits, calibrators, controls 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.

Quality & Regulatory Compliance:

• Ensure manufacturing operations comply with applicable 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 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.

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.

Supply Chain & Procurement:

• Work closely with Procurement and Supply Chain teams to ensure uninterrupted availability of critical medical device/IVD 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.

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 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.

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.

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.

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.

Candidate Profile:

• 18-25+ years of experience in manufacturing/operations.
• Strong experience in IVD, diagnostics, medical devices, biotechnology, life sciences, pharma, reagents or related regulated manufacturing.
• Experience managing large-scale manufacturing operations and multiple functions.
• Strong understanding of quality and regulatory systems.
• Proven experience in capacity expansion, plant setup, automation and operational excellence.
• Experience in new product scale-up and technology transfer.
• Strong commercial and financial understanding.
• Experience managing cross-functional teams and senior stakeholders.
• Strong exposure to international customers/audits would be preferred.