Plant Head

Job Description:

• Oversee end-to-end manufacturing operations across all sterile/aseptic product lines
• Scale production capacity to support 2X revenue growth through CMO partnerships and captive expansion
• Drive Industry 4.0 transformation: automation, IoT, MES, data analytics, and AI-driven optimization
• Ensure GMP compliance and maintain the highest quality standards
• Manage CDSCO, EMA, EU MDR, and international regulatory audits with zero critical observations
• Lead capacity expansion, technology transfers, and new product introductions
• Develop and manage CMO relationships while optimizing captive production capabilities
• Support export market expansion through compliance excellence and production scalability
• Implement Lean Manufacturing, Six Sigma, and continuous improvement initiatives
• Build and develop high-performing production teams across multiple shifts
• Establish competitive benchmarking systems and drive market leadership in quality and efficiency

• 12-18 years in pharmaceutical manufacturing with 5-7 years in leadership roles
• Extensive experience with sterile/aseptic operations (PFS, vials, LVP, SVP)
• Track record with ophthalmic or injectable product manufacturing
• Experience with CMO operations and capacity scaling strategies
• Preferred: Experience with top-tier companies

• Proven experience leading digital transformation in pharmaceutical manufacturing
• Expertise in automation, MES, SCADA, IoT, data analytics, and AI/ML applications

• Extensive CDSCO inspection and compliance experience (Schedule M requirements)
• Strong track record with FDA inspections and surveillance audits
• In-depth experience with CE marking, PMA/ MAA, and Notified Body audits

• Deep understanding of GMP, aseptic processing, and sterility assurance
• Knowledge of validation protocols, process validation, and risk management (FMEA, HACCP)
• Strong leadership, strategic thinking, and change management capabilities