Job Description:

Position Summary

We are seeking an exceptional leader to drive operational excellence, scale manufacturing capabilities, and achieve global competitiveness while ensuring compliance with CDSCO, EMA, and EU MDR requirements.

Key Responsibilities

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Oversee end-to-end manufacturing operations across all sterile/aseptic product lines

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Scale production capacity to support 2X revenue growth through CMO partnerships and captive expansion

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Drive Industry 4.0 transformation: automation, IoT, MES, data analytics, and AI-driven optimization

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Ensure GMP compliance and maintain the highest quality standards

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Manage CDSCO, EMA, EU MDR, and international regulatory audits with zero critical observations

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Lead capacity expansion, technology transfers, and new product introductions

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Develop and manage CMO relationships while optimizing captive production capabilities

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Support export market expansion through compliance excellence and production scalability

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Implement Lean Manufacturing, Six Sigma, and continuous improvement initiatives

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Build and develop high-performing production teams across multiple shifts

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Establish competitive benchmarking systems and drive market leadership in quality and efficiency

Required Experience & Skills

Manufacturing Expertise

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12-18 years in pharmaceutical manufacturing with 5-7 years in leadership roles

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Extensive experience with sterile/aseptic operations (PFS, vials, LVP, SVP)

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Track record with ophthalmic or injectable product manufacturing

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Experience with CMO operations and capacity scaling strategies

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Preferred: Experience with top-tier companies

Industry 4.0 & Technology

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Proven experience leading digital transformation in pharmaceutical manufacturing

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Expertise in automation, MES, SCADA, IoT, data analytics, and AI/ML applications

Regulatory Compliance

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Extensive CDSCO inspection and compliance experience (Schedule M requirements)

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Robust track record with FDA inspections and surve

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