General Manager - Projects (API Pharma)

piramalpharma; Digwal; On-site; INR 6,000,000 - 10,000,000; Full time

Job summary

Piramal Pharma Solutions in Digwal is seeking a General Manager - Projects (API Pharma) to lead end-to-end project activities for new API facilities. You will drive concept to commissioning, Manage schedules, budgets, and cross-functional teams while ensuring strict GMP and regulatory compliance across global sites.

Ideal candidates will have 20+ years of API project management experience, strong engineering background, and ability to coordinate with R&D, manufacturing, and QA.

Qualifications

• Minimum 20+ years in API or bulk drug project management, ideally with top pharma firms.
• Experience leading greenfield and brownfield API facilities from concept to commissioning.
• Strong GMP facility design understanding and cross-functional leadership.

Responsibilities

• Lead end-to-end project management for new API manufacturing facilities and expansions.
• Develop schedules, budgets, timelines, and resource plans using Primavera or MS Project.
• Coordinate with consultants, EPCs, and QA for timely delivery and compliance.
• Oversee IQ/OQ/PQ, utilities, and cleanroom systems to ensure quality and safety.
• Ensure regulatory readiness and effective communication with stakeholders.

Skills

Project management

Cross-functional coordination

GMP facility design

Regulatory compliance

Budget & cost control

Vendor & contract management

Technical leadership

Education

B.E./B.Tech/M.Tech in Chemical Engineering

PM Certification (advantage)

Tools

Primavera

MS Project

Job description

Division

Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

General Manager - Projects (API Pharma)

Job Description

General Manager - Projects (API Pharma) will be responsible for leading and managing end-to-end project activities for Greenfield and Brownfield API (Active Pharmaceutical Ingredient) manufacturing facilities at Digwal locations. The incumbent will oversee all phases of the project lifecycle-conceptualization, design, engineering, procurement, construction, installation, commissioning, and handover-ensuring timely delivery, adherence to budget, and full compliance with cGMP, EHS, and regulatory standards. This role requires a highly skilled project management professional with a strong background in pharmaceutical engineering, process design, and cross-functional coordination, capable of managing complex projects while driving excellence in quality, safety, and cost-effectiveness.

General Manager - Projects (API Pharma)

Band: 4

Department: Global Engineering & Projects

Location: Digwal

Reports To: Sr. VP Global Head Project / Engg

Employment Type: Full-time / Permanent

Key Responsibilities

1. 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.

Qualifications & Experience

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 ,