General Manager - Projects (API Pharma)

Role overview

Project planning and execution

• Lead projects for new API facilities, plant expansions, and capacity enhancement.
• Manage project schedules, budgets, timelines, and resource plans using Primavera or MS Project.
• Coordinate consultants, architects, and EPC contractors across engineering, procurement, and construction.
• Drive installation, commissioning, and IQ/OQ/PQ qualification of process, utility, and ancillary systems.

Engineering and coordination

• Review PFDs, P&IDs, equipment data sheets, and layout drawings; ensure design aligns with cGMP and regulatory standards.
• Support technology transfer, process scale-up, and equipment selection with R&D and Manufacturing.
• Provide technical leadership for WFI, clean steam, HVAC, chillers, compressed air, and cleanroom design.
• Coordinate internal functions and lead site-based teams; manage external partners, consultants, suppliers, and contractors.

Compliance, reporting, and performance

• Maintain EHS and quality standards, conduct HAZOP and risk assessments, and support regulatory audits and inspections.
• Prepare progress, risk, deviation, and project health reports; maintain GMP and project documentation.
• Track KPIs, milestones, budgets, and financial targets; recommend corrective actions and report to senior management.

Education and experience

• B.E., B.Tech, or M.Tech in Chemical Engineering.
• At least 20 years of API or bulk drug project management experience.
• Proven execution of Greenfield and Brownfield projects from concept to commissioning, including experience handling multiple projects.
• Strong understanding of GMP facility design, process equipment, utilities, and HVAC systems.
• Familiarity with USFDA, EMA, MHRA, and WHO guidelines; proficiency in Primavera, MS Project, and AutoCAD.
• Project Management certification is an added advantage.

Leadership and travel

• Requires leadership, people management, communication, negotiation, stakeholder management, analytical problem-solving, and decision-making capabilities.
• Requires willingness to travel extensively domestically and internationally based on project needs.