General Manager Operations / Plant Head Operations - API Manufacturing

Role & responsibilities :

• Lead end-to-end plant operations covering Production, R&D, Engineering, Maintenance, Utility Operations, Warehouse, EHS, and Projects.
• Ensure achievement of production plans, capacity utilization, yield improvement, and on-time product delivery.
• Drive operational excellence through process optimization, cycle time reduction, solvent recovery improvement, and cost reduction initiatives.
• Ensure compliance with cGMP, USFDA, EU GMP, WHO-GMP, ICH Guidelines, Data Integrity, and EHS regulations.
• Lead successful regulatory inspections, customer audits, and quality compliance programs.
• Manage multi-purpose API manufacturing blocks involving complex chemical reactions, hydrogenation, high-pressure operations, and solvent handling systems.
• Oversee engineering, preventive maintenance, utilities, and reliability programs to ensure uninterrupted operations.
• Lead technology transfer, scale-up activities, debottlenecking, and capacity expansion projects.
• Drive implementation of Lean Manufacturing, TPM, Six Sigma, and continuous improvement initiatives.
• Ensure adherence to process safety management, environmental compliance, hazardous chemical handling, and sustainable manufacturing practices.
• Develop high-performing teams and foster a culture of accountability, safety, quality, and operational excellence.

Preferred candidate profile :

• Qualification: B.Tech/B.E. Chemical Engineering, M.Sc. Chemistry, M.Pharm or equivalent; MBA preferred.
• Experience: 18-25 years in Pharmaceutical API/Bulk Drug manufacturing with at least 8 years in senior plant leadership roles.
• Proven experience managing USFDA, EDQM, MHRA, PMDA, WHO-GMP approved facilities.
• Strong exposure to API process manufacturing, solvent recovery systems, utility management, process optimization, and regulatory compliance.
• Demonstrated success in leading large teams, expansion projects, and operational excellence programs.