Project Manager (Pharmaceutical Formulation Factory Setup)

Job Overview:
We are seeking a highly experienced and motivated Project Manager to lead the end-to-end development of our new pharmaceutical formulation factory. The ideal candidate will have demonstrated expertise in factory setup under GMP guidelines, with a focus on creams, gels, and external-use preparations, as well as a comprehensive understanding of regulatory requirements and manufacturing processes.
Key Responsibilities:
1. Factory Setup and Design:
• Lead the project lifecycle, from initial conceptualization to operational readiness.
• Design production lines for formulations such as creams, gels, and external-use products, ensuring compliance and scalability.
• Collaborate with architects, contractors, and engineers to align factory design with operational and regulatory standards.
2. Production Line and Equipment:
• Source, evaluate, and install manufacturing and packaging equipment in compliance with global standards.
• Oversee the integration of production workflows to optimize efficiency and minimize downtime.
3. Regulatory Compliance:
• Ensure adherence to GMP (WHO) and ASEAN regulatory guidelines throughout the factory setup process.
• Develop and implement processes to maintain ongoing compliance with industry standards.
4. Project Management:
• Create detailed project plans, budgets, and timelines; monitor and report on project progress.
• Proactively manage risks and address challenges to meet critical deadlines.
• Collaborate with internal teams, regulatory agencies, and external consultants to align project objectives.
5. Team Building and Leadership:
• Recruit and build key teams such as R&D, Quality Assurance, and Production to deliver project outcomes.
• Serve as the primary point of contact for international suppliers, contractors, and stakeholders.
6. Commercialization and Operations:
• Manage the transition from setup to full-scale production and commercialization.
• Establish quality control measures, supply chain systems, and workforce training programs.