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Job Title: President – Manufacturing Operations (Formulations) Location: Dholka, Ahmedabad Scope: Manufacturing Operations across Dholka, Jammu & Udaipur Role Summary The President – Manufacturing Operations (Formulations) will provide strategic and operational leadership for multiple pharmaceutical formulation manufacturing sites across Dholka, Jammu and Udaipur, covering OSD and Injectable operations. The role will be responsible for driving manufacturing excellence, quality and regulatory compliance, operational efficiency, cost optimization, capacity enhancement and leadership development across the manufacturing network. The ideal candidate will have a proven track record of managing multiple formulation plants, operating in highly regulated markets and successfully leading USFDA inspections with zero observations in the last 3 years.

Key Responsibilities Multi-Site Manufacturing Leadership Provide end-to-end leadership for manufacturing operations across multiple formulation plants at Dholka, Jammu and Udaipur. Oversee OSD and Injectable manufacturing, ensuring adherence to quality, productivity, cost, delivery and EHS objectives. Drive capacity utilization, manufacturing productivity, yield improvement, OEE and operational excellence across sites.

Lead implementation of Lean, Six Sigma, TPM and continuous improvement initiatives. Quality & Regulatory Leadership Ensure compliance with USFDA, EU-GMP, WHO-GMP, MHRA and other applicable global regulatory requirements. Partner with QA, QC and Regulatory teams to maintain inspection readiness and a robust quality culture.

Mandatory: Proven experience of facing/leading USFDA inspections at formulation manufacturing sites within the last 3 years,



with zero observations. Drive robust systems for deviation management, CAPA, change control, data integrity and right-first-time manufacturing.

Strategic

Manufacturing &

• Business Support Develop and execute the manufacturing strategy aligned with business growth, product launches and market expansion. Lead technology transfer, scale-up, commercialization and manufacturing readiness for new products. Drive capacity expansion, plant modernization, automation and technology upgradation. Provide strategic inputs for Capex planning and long-term manufacturing investments. Financial &

• Operational Performance Own manufacturing budgets and drive cost optimization and margin improvement. Monitor and improve key manufacturing KPIs including OEE, yield, productivity, RFT, deviations, batch rejection and cost per unit. Work closely with Supply Chain, Quality, Engineering and Business teams to ensure uninterrupted manufacturing operations. People &

• Leadership Lead and mentor Plant Heads and senior manufacturing leadership teams across locations. Build a high-performance culture focused on quality, compliance, accountability, safety and continuous improvement. Drive succession planning, leadership development and capability building across manufacturing functions. EHS &





• Sustainability Ensure highest standards of occupational safety, EHS and statutory compliance across all plants. Drive initiatives around energy efficiency, waste reduction, sustainability and environmental performance.

Educational

Qualification B.Pharm / M.Pharm / Chemical Engineering – Mandatory MBA / Advanced Management qualification preferred.

Experience & Candidate Profile 20+ years of progressive experience in pharmaceutical manufacturing, with substantial experience in formulation manufacturing. Mandatory experience managing multiple formulation manufacturing plants/sites. Strong exposure to both OSD and Injectable formulations.

Proven experience in managing large-scale manufacturing operations through Plant Heads/Site Leadership Teams. Mandatory recent USFDA inspection experience, with successful USFDA audits having zero observations within the last 3 years. Strong exposure to US, EU and other regulated markets.

Demonstrated experience in manufacturing strategy, operational excellence, capacity expansion, Capex and cost optimization. Strong understanding of cGMP, quality systems, regulatory compliance and inspection readiness.

Experience in technology transfer, scale-up and commercialization will be preferred. Strong business acumen, stakeholder management and people leadership capabilities.

Ideal

Candidate A senior pharmaceutical manufacturing leader who has managed multiple formulation plants at a Group/Corporate level, with strong OSD & Injectable manufacturing experience, a proven record of operational and financial performance, and recent successful USFDA inspections with zero observations.

📌 President (Dholka)
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📍 Dholka