General Manager - API Projects

Role & responsibilities

Project Planning & Execution

• Lead end-to-end project management for new API manufacturing facilities, plant expansions, and capacity enhancement projects.
• Develop and manage project schedules, budgets, timelines, and resource plans using tools such as Primavera or MS Project.
• Coordinate with consultants, architects, and EPC contractors for basic and detailed engineering, procurement, and construction activities.
• Drive installation, commissioning, and qualification (IQ/OQ/PQ) of process, utility, and ancillary systems.
• Ensure on-time delivery of projects within approved budgets and scope.

2. Engineering & Technical Oversight

• Review and approve Process Flow Diagrams (PFDs), Piping & Instrumentation Diagrams (P&IDs), equipment data sheets, and layout drawings.
• Ensure engineering design adheres to cGMP, USFDA, EMA, MHRA, and WHO standards.
• Support technology transfer, process scale-up, and equipment selection in coordination with R&D and Manufacturing teams.
• Provide technical leadership in areas such as utilities (WFI, clean steam, HVAC, chillers, compressed air) and cleanroom design.

3. Cross-Functional Coordination

• Collaborate closely with internal teams including Production, Quality Assurance, Quality Control, Regulatory Affairs, EHS, and Procurement for smooth execution.
• Work with Finance and Procurement for cost estimation, vendor selection, contract negotiation, and budget tracking.
• Lead site-based project teams, ensuring effective communication, accountability, and goal alignment.
• Build strong relationships with external partners, consultants, and suppliers to ensure best-in-class project delivery.

4. Compliance, Quality & Safety

• Ensure strict adherence to EHS (Environment, Health & Safety) and Quality Management standards throughout project execution.
• Conduct Hazard and Operability Studies (HAZOP), risk assessments, and implement mitigation strategies.
• Ensure all activities comply with statutory, local, and international regulatory requirements.
• Support readiness for regulatory audits and inspections related to project and facility setup.

5. Reporting & Documentation

• Prepare comprehensive project reports, including progress updates, risk analysis, and deviation reports, for senior management.
• Maintain accurate documentation as per GMP and project management protocols.
• Track project performance against defined KPIs and milestones, recommending corrective actions as needed.
• Present updates in management review meetings and provide visibility into project health and financial status.

Preferred candidate profile

Education:

• B.E./B.Tech/M.Tech in Chemical Engineering
• Project Management certification will be an added advantage.

Experience:

• Minimum 20 + years of experience in API or bulk drug project management, preferably with leading pharmaceutical companies.
• Proven experience in executing Greenfield and Brownfield projects from concept to commissioning.
• Exposure to Multiple Projects handling
• Strong understanding of GMP facility design, process equipment, utilities, and HVAC systems.
• Familiarity with international regulatory guidelines USFDA, EMA, MHRA, WHO.
• Proficiency in project management tools such as Primavera, MS Project, and AutoCAD.

Key Competencies & Skills

• Strong leadership and people management skills; ability to lead cross-functional teams.
• Excellent communication, negotiation, and stakeholder management capabilities.
• Strategic thinker with a hands-on execution approach.
• Strong analytical, problem-solving, and decision-making abilities.
• Demonstrated ability to manage budgets, timelines, and multiple priorities under pressure.
• Commitment to quality, safety, and regulatory compliance.
• Willingness to travel extensively (domestic and international) based on project needs.

Key Performance Indicators (KPIs)

• Timely completion of projects within approved budget and scope.
• Compliance with regulatory, safety, and quality standards.
• Effective vendor and contractor management.
• Achievement of project milestones and financial targets.
• Stakeholder satisfaction and cross-functional collaboration effectiveness.