Position Overview
The Assistant 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 across domestic and international 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.
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
Experience:
- Minimum 15+ 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 multi-location projects (India and/or international sites).
- 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.
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers 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 such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
