Production Management Plan, coordinate, and supervise daily API manufacturing activities in line with the approved production plan. Ensure timely execution and completion of batches as per BMR/BPR, SOPs, process parameters, and manufacturing instructions. Supervise manufacturing operations including reaction, charging, heating/cooling, extraction, distillation, crystallization, filtration, centrifugation, drying, milling, and packing, as applicable. Monitor critical process parameters and ensure compliance with validated process ranges. Review batch progress, production output, yield, cycle time, and resource utilization. Ensure optimum utilization of manpower, equipment, raw materials, solvents, and utilities. Take timely corrective action for process delays, yield variation, equipment issues, and other production constraints. 2. Team Leadership Lead and supervise Production Executives, Officers, and Operators. Plan manpower deployment and shift-wise activities according to production requirements. Set work priorities and monitor team performance. Provide technical guidance and on-job training to production personnel. Develop team competency in GMP, manufacturing processes, safety, documentation, and equipment operation. Promote a strong culture of quality, safety, compliance, and operational discipline. 3. GMP & Compliance Ensure compliance with cGMP, SOPs, BMR/BPR, GDP, data-integrity principles, and site quality systems. Ensure proper completion and review of manufacturing documentation. Ensure line clearance, area clearance, equipment cleaning, status labeling, and process verification are completed appropriately. Ensure manufacturing activities comply with approved procedures and regulatory requirements. Support preparation for and participation in internal, customer, and regulatory audits. Ensure timely implementation of audit observations and compliance actions related to Production. 4. Deviations, CAPA & Change Control Lead/support investigations related to process deviations, incidents, yield discrepancies, equipment failures, and manufacturing issues. Participate in root-cause analysis and development of effective CAPA. Initiate and implement change controls related to production processes and equipment. Review and implement corrective actions to prevent recurrence of manufacturing problems. Support OOS/OOT investigations when production-related factors are involved. 5. Process & Technical Support Troubleshoot manufacturing process issues and provide technical solutions. Analyze batch trends, process performance, yield, and cycle-time data. Identify opportunities for process optimization, yield improvement, cycle-time reduction, and solvent/raw-material efficiency. Support process validation, cleaning validation, continued process verification, scale-up, and technology-transfer activities. Work with R&D/Process Development teams during new product introduction and process improvements. 6. Equipment & Maintenance Ensure availability and proper functioning of production equipment. Coordinate with Engineering for equipment breakdowns, preventive maintenance, calibration, and qualification activities. Participate in equipment qualification and modification projects. Ensure production equipment is operated and maintained according to approved procedures. 7. Cross-Functional Coordination Coordinate closely with QA, QC, Engineering, Warehouse, EHS, R&D/Process Development, and Planning. Ensure timely availability of raw materials, solvents, equipment, manpower, and other resources. Coordinate with QC for sampling and testing of intermediates and APIs. Work with QA on batch documentation, deviations, investigations, and batch disposition. Coordinate with EHS for safe handling of chemicals, solvents, gases, and hazardous operations. 8. Safety & EHS Ensure strict compliance with plant safety procedures and PPE requirements. Identify and control operational risks associated with chemical reactions, solvent handling, pressure/vacuum operations, and process equipment. Ensure employees are trained in safe operating procedures and emergency response. Promote safe working practices and report unsafe conditions and incidents. Educational Qualification M.Sc. in Chemistry / Organic Chemistry B.Sc. Chemistry with relevant API production experience may also be considered. B.Pharm / M.Pharm / Chemical Engineering may be considered depending on the organization and manufacturing process. Experience Typically 6–10 years of relevant experience in API Production. Strong experience in API manufacturing, chemical synthesis, GMP operations, and team management. Experience in a regulated pharmaceutical manufacturing environment is preferred. Exposure to regulatory/customer audits such as USFDA, EMA, WHO, or other regulatory agencies is advantageous. Technical Competencies API manufacturing and chemical synthesis Reaction chemistry and process control Crystallization / precipitation Extraction and distillation Filtration / centrifugation Drying and milling Solvent recovery and handling Batch manufacturing and documentation cGMP / GDP / Data Integrity Deviation / CAPA / Change Control Process and cleaning validation Root-cause analysis Process optimization and troubleshooting EHS and chemical safety Key Performance Indicators (KPIs) Achievement of production targets Batch completion within planned timelines Yield and productivity improvement Reduction in cycle time Right-first-time batch execution Reduction in manufacturing deviations GMP and documentation compliance Equipment utilization and availability Manpower productivity Solvent/raw-material efficiency Safety performance Timely closure of CAPA and investigation actions Core Competencies Leadership and people management Strong technical and process knowledge Decision-making and problem-solving Production planning Root-cause analysis