API Manufacturing operations:- Ankleshwar

Cadila Pharmaceuticals Limited; Ankleshwar; On-site; INR 7,000,000 - 9,000,000; Full time

Job summary

Cadila Pharmaceuticals Limited seeks a visionary Head of API Manufacturing to lead end-to-end API production across facilities, ensuring target achievement, quality, and regulatory compliance in a fast-paced environment.

You will drive operational excellence, CAPEX projects, and cross-functional collaboration with QA/QC, SCM, R&D, and Regulatory Affairs to secure uninterrupted supply of APIs.

Qualifications

• Extensive senior leadership experience in API manufacturing operations.
• Track record of delivering regulatory compliance and quality excellence.
• Proven ability to drive cost optimization and productivity gains.
• Experience leading CAPEX projects and facility upgrades.

Responsibilities

• Develop and execute strategic operations plans for API manufacturing.
• Lead end-to-end API production scheduling, batch planning, and dispatch.
• Ensure cGMP, WHO-GMP, USFDA/EU-GMP compliance and audit readiness.
• Drive cost reduction, process optimization, and utility efficiency.
• Oversee CAPEX projects, infrastructure upgrades, and commissioning.

Skills

Strategic leadership

API manufacturing

Regulatory compliance

Cost optimization

OEE & productivity

CAPEX planning

EHS & process safety

Cross-functional coordination

Job description

Job Purpose

To provide strategic and operational leadership for Active Pharmaceutical Ingredient (API) manufacturing operations across manufacturing facilities, ensuring achievement of production targets, operational excellence, cost optimization, quality compliance, EHS standards, and business objectives.

The role will be responsible for driving manufacturing efficiency, capacity utilization, process improvements, regulatory compliance, and development of a high-performance operations team while ensuring uninterrupted supply of APIs as per business requirements.

2. Key Responsibilities

A. Strategic Operations & Business Performance

• Develop and execute the annual manufacturing and operational strategy aligned with organizational business objectives.
• Lead API manufacturing operations to achieve production targets, productivity, yield, and cost objectives.
• Ensure adherence to the annual operating plan, production budgets, and PBT targets.
• Drive operational excellence through improved manufacturing processes, resource optimization, and productivity enhancement.
• Monitor key operational KPIs, identify gaps, and implement corrective and preventive action plans.
• Ensure optimum utilization of manufacturing capacities, manpower, utilities, and infrastructure.

B. API Manufacturing & Production Management

• Oversee end-to-end API manufacturing operations, including process execution, batch planning, production scheduling, and dispatch coordination.
• Ensure timely execution of production plans in line with market demand and supply commitments.
• Monitor batch yields, cycle times, solvent recovery, rejection rates, and manufacturing efficiencies.
• Ensure strict adherence to approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), and process parameters.
• Drive right-first-time production, process consistency, and reduction in batch failures and deviations.
• Ensure effective coordination with Production Planning, QA, QC, Engineering, SCM, and Regulatory Affairs.

C. Quality & Regulatory Compliance

• Ensure compliance with cGMP, WHO-GMP, USFDA, EU-GMP, and other applicable regulatory requirements.
• Drive a strong quality culture across manufacturing operations.
• Ensure timely closure of deviations, CAPAs, change controls, audit observations, and investigations.
• Support regulatory inspections and customer audits, ensuring audit readiness at all times.
• Ensure effective implementation of data integrity, documentation practices, and quality systems.
• Collaborate with QA and QC teams to maintain product quality and regulatory compliance.

D. Cost Optimization & Operational Excellence

• Drive manufacturing cost reduction through process optimization, yield improvement, and reduction in material consumption.
• Optimize solvent recovery, energy consumption, water usage, and utility costs.
• Identify opportunities for process improvements, automation, and technology upgrades.
• Benchmark manufacturing performance against industry standards and implement best practices.
• Improve overall equipment effectiveness (OEE), equipment utilization, and plant productivity.

E. CAPEX & Infrastructure Development

• Identify and propose CAPEX requirements for capacity enhancement, technology upgradation, and infrastructure development.
• Lead execution of approved CAPEX projects within defined budgets and timelines.
• Ensure commissioning and qualification of new manufacturing facilities and equipment.
• Drive facility modernization and ensure infrastructure readiness for future business growth.
• Ensure timely completion of engineering projects and cGMP-related facility upgrades.

F. EHS & Process Safety Management

• Ensure compliance with Environment, Health and Safety (EHS) policies and statutory requirements.
• Drive process safety management, hazard identification, risk assessment, and mitigation.
• Ensure implementation of HAZOP, risk assessment, incident investigation, and emergency preparedness.
• Monitor occupational safety, environmental performance, effluent treatment, and waste management.
• Promote a zero-incident and safety-first culture across manufacturing facilities.

G. Supply Chain & Cross-Functional Coordination

• Coordinate with SCM, Procurement, QA, QC, Engineering, R&D, and Regulatory teams to ensure uninterrupted manufacturing operations.
• Ensure availability of critical raw materials, solvents, intermediates, and packaging materials.
• Support production planning and inventory optimization.
• Ensure timely delivery of finished APIs as per agreed customer and business commitments.
• Resolve operational bottlenecks affecting production and supply continuity.

H. People Leadership & Organization Development

• Lead and mentor plant heads, production heads, and cross-functional operations teams.
• Build a strong second line of leadership and succession pipeline.
• Drive performance management, capability development, and technical training.
• Establish accountability, ownership, and a performance-driven culture.
• Ensure effective manpower planning and productivity improvement.