General Manager -CDMO (API)- US , Europe Market

Key Responsibilities:

Business Development & Client Management

• Identify, acquire, and manage global clients in the API CDMO space across US, EU, Japan, and RoW markets.
• Build strategic partnerships with innovator pharma, biotech, and specialty pharma companies.
• Lead high-level client interactions, proposal development, pricing strategy, and contract negotiations.
• Maintain long-term client relationships and ensure repeat business through high-quality service delivery.

Project & Portfolio Leadership

• Oversee the entire lifecycle of client projects, from R&D and process development to scale-up and commercial manufacturing.
• Ensure timely, cost-effective, and compliant delivery of client projects.
• Prioritize projects based on strategic value and allocate internal resources efficiently across portfolios.

Technical & Regulatory Oversight

• Collaborate with internal teams in process chemistry, analytical development, technology transfer, QA, and RA.
• Ensure adherence to international regulatory standards (USFDA, EMA, PMDA, WHO).
• Support clients in the preparation and filing of regulatory dossiers including DMFs, ANDAs, and CTDs.

Operations & Supply Chain Management

• Optimize operational efficiency in commercial API manufacturing facilities.
• Drive plant utilization, ensure quality compliance, and enable scalability of operations.
• Collaborate with procurement and supply chain for timely sourcing of raw materials and vendor coordination.

Strategic & P&L Leadership

• Own the P&L of the global API CDMO business and ensure sustainable profitability.
• Define and implement long-term growth strategies including capacity expansion, service differentiation, and new market entry.
• Monitor financial KPIs, margins, cost structures, and drive initiatives for new revenue streams.