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

ConfidentialAhmedabad

8 days ago

Job description

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.

Skills Required

Api Development

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