Deputy General Manager, Manufacturing API

Amneal Pharmaceuticals is seeking a highly experienced and strategic Deputy General Manager – Manufacturing API to lead peptide API manufacturing operations with a strong focus on technical excellence, regulatory compliance, and operational efficiency. The involves overseeing end-to-end peptide manufacturing processes, driving process optimization and scale-up, ensuring compliance with global regulatory standards, and leading cross-functional collaboration.

Roles & Responsibilities

• Provide technical leadership in solid-phase and liquid-phase peptide synthesis (SPPS/LPPS) including advanced and hybrid technologies.
• Drive process development, optimization, and technology transfer for peptide APIs.
• Lead scale-up activities ensuring process robustness, reproducibility, and consistency across batch sizes.
• Review and approve manufacturing strategies from early-stage development to final API production.
• Oversee end-to-end peptide manufacturing including synthesis, cleavage, purification (preparative chromatography), and lyophilization.
• Ensure efficient plant operations with optimal utilization of manpower, equipment, and resources.
• Monitor production plans and ensure timely execution of manufacturing schedules.
• Oversee utilities such as steam, vacuum, chilled water, and ensure uninterrupted operations.
• Ensure compliance with cGMP, USFDA, and other global regulatory requirements.
• Provide oversight for DMF preparation, review, submission, and lifecycle management.
• Review and approve Batch Manufacturing Records (BMRs), deviations, CAPA, and change controls.
• Lead and manage regulatory inspections, audits, and ensure audit readiness at all times.
• Drive continuous improvement in manufacturing processes and operational efficiency.
• Lead preparation of URS and oversee qualification activities including DQ, IQ, OQ, and PQ.
• Coordinate with engineering teams for equipment installation, maintenance, and reliability improvements.
• Manage breakdowns, preventive maintenance, and ensure high equipment uptime.
• Collaborate with QA, QC, Warehouse, and R&D teams for process improvements and scale-up strategies.
• Ensure proper handling, storage, and reconciliation of raw materials, intermediates, and APIs.
• Monitor and optimize inventory levels of consumables and critical materials.
• Ensure accuracy, completeness, and compliance of all GMP documentation and records.
• Oversee in-process sampling, testing, and quality checks during manufacturing.
• Promote adherence to safety protocols, PPE usage, and environmental guidelines.
• Ensure proper handling, storage, and disposal of hazardous materials.
• Drive a strong culture of GMP compliance, quality assurance, and safety across the facility.
• Provide leadership, guidance, and mentoring to team members to enhance performance.