Production Head

Responsible for leading end-to-end manufacturing operations in FTO-9 Production predominantly focusing on Complex Injectables pertaining to Octreotide, Microspheres etc ensuring safe, compliant, and efficient execution of sterile manufacturing activities.

The incumbent will drive Complex Injectable Manufacturing - including new product introductions, technology transfer, commercial-scale production, sterility assurance, and continuous improvement initiatives while ensuring adherence to cGMP, quality, safety, and regulatory requirements.

Key Responsibilities

Production Operations

• Lead and manage manufacturing and filling operations in FTO-9 Production.
• Ensure availability of manpower, machinery, materials, and utilities to achieve production targets.
• Drive execution of monthly production plans and ensure timely delivery as per business requirements.
• Monitor and improve productivity, yield, capacity utilization, and operational excellence across manufacturing processes.
• Oversee compounding operations, water systems, and associated production activities.
New Product Introduction & Technology Transfer

• Lead New Product Introduction (NPI) activities and manufacturing readiness initiatives.
• Manage technology transfer projects from R&D; and external sites to commercial manufacturing.
• Coordinate cross-functional activities for process validation, equipment qualification, and successful product commercialization.
• Ensure seamless scale-up and transfer of complex injectable products.
Sterile Manufacturing & Compliance

• Ensure compliance with aseptic practices and sterile manufacturing requirements in Grade-C and controlled environments.
• Participate and provide leadership in media fills, sterilization activities, Isolator VHP qualifications, and sterility assurance programs.
• Ensure adherence to cGMP, data integrity, and regulatory requirements.
• Review and approve GMP documents including SOPs, BMRs, URS, protocols, reports, and related quality documentation.
Quality & Investigation Management

• Review and approve investigations, deviations, OOS, incidents, CAPAs, and change controls.
• Coordinate with QA, QC, Engineering, Warehouse, SHE, Administration, F&D;, and TTG for issue resolution and compliance activities.
• Ensure product quality and batch yield remain within specified limits.
• Support audit readiness and regulatory inspection preparedness.
Engineering & Project Management

• Coordinate with Engineering teams for equipment reliability, maintenance, and operational excellence.
• Review and approve Purchase Requisitions, CAPEX proposals, and project requirements.
• Participate in facility expansion, equipment qualification, automation, and process improvement initiatives.
• Conduct regular Gemba walks and shop-floor reviews to drive continuous improvement.
Training & Team Development

• Act as a qualified trainer and impart technical and GMP training to manufacturing personnel.
• Ensure timely completion of LMS trainings and competency assessments.
• Build a high-performance team culture focused on safety, quality, compliance, and productivity.
Audits & Regulatory Compliance

• Participate in internal, customer, and regulatory audits.
• Lead audit response preparation and implementation of corrective and preventive actions.
• Ensure closure of observations within agreed timelines.
Key skills required: 

• Proven experience in sterile injectable manufacturing operations.
• Strong exposure to Microspheres manufacturing and associated aseptic processing operations.
• Hands-on experience in Complex Injectable Manufacturing, including technology transfer and commercial-scale production.
• Experience in handling SKID systems, process equipment integration, and utility coordination.
• Exposure to compounding, filling, sterilization, water systems, and isolator-based manufacturing.
• Strong understanding of cGMP, regulatory compliance, investigation management, and sterility assurance programs.
• Experience in new product introduction, validation, qualification, and process optimization.

Function: Manufacturing
Experience Level: Mid-Senior Level