External Manufacturing Organization (CMO) Coordination Intas

5.0 - 10.0 years

20 - 25 Lacs

Ahmedabad

Work from Office

Role & responsibilities 1. Demand Forecasting & Supply Planning Collaborate with global commercial teams to collect, consolidate, and validate monthly and long-term demand forecasts for EU and US markets. Translate market demand into supply plans for external manufacturing partners (CMOs) while factoring in lead times, batch sizes, MOQs, and regulatory constraints. Ensure alignment between supply capabilities and sales forecast to meet customer service levels and avoid stock-outs or excess inventory. 2. CMO Coordination Technology Transfer Support: Participate in coordination of scale-up, validation, and technology transfer to external sites. Communicate monthly and rolling production schedules to CMOs, ensuring timely manufacturing and dispatch of finished goods. Monitor and track CMO production milestones, highlighting and resolving delays, bottlenecks, or deviations from plan. Coordinate between CMOs and internal teams for timely availability of materials (API, packaging components) required for production. 3. Inventory & Logistics Management Maintain optimal inventory levels across internal warehouses and at CMOs to ensure uninterrupted supply and regulatory compliance. Liaise with distribution and logistics teams to manage dispatches from CMOs to domestic or international destinations. Track shipments, ensure documentation readiness (COA, COE, batch records), and coordinate with regulatory and QA for release. 4. Regulatory & Quality Alignment Ensure compliance with EU-GMP, USFDA, and global regulatory requirements at all stages of CMO production and supply chain. Coordinate with Quality Assurance for batch release, deviation handling, CAPA tracking, and quality agreements with CMOs. Support audit readiness for EU/US inspections and customer audits at external sites. 5. Cross-Functional Collaboration Act as the operational bridge between Commercial, QA, Regulatory, Manufacturing, Procurement, and the CMO partners. Lead S&OP discussions from the external manufacturing supply side, sharing risk-based insights on supply gaps or delays. 6. KPI Monitoring & Reporting Monitor and report on key supply chain performance indicators including OTIF (On Time In Full), forecast accuracy, inventory turns, production adherence, and lead time compliance. Prepare weekly/monthly dashboards for internal reviews and global stakeholder communication. 7. Change & Risk Management Manage change control processes in coordination with Regulatory and QA for site, pack, or process-related changes at CMOs. Identify and mitigate risks related to capacity constraints, regulatory barriers, quality issues, or supply disruptions. Preferred candidate profile Candidate must have experience to work with CMO and international client handling.

Posted 1 week ago

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