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

Role Objective:

Contract Development & Manufacturing Organization (CDMO) business for Active Pharmaceutical Ingredients (APIs)

Key Responsibilities:

1. Business Development & Client Management

• Identify and acquire global clients for API CDMO services (US, EU, Japan, RoW markets).
• Build strong partnerships with innovator, biotech, and specialty pharma companies.
• Lead contract negotiations, pricing, and long-term agreements.

2. Project & Portfolio Leadership

• Oversee end-to-end lifecycle: R&D Process Development Scale-up Commercial Manufacturing.
• Ensure on-time delivery of client projects with quality, safety, and compliance standards.
• Manage portfolio prioritization and resource allocation across multiple client projects.

3. Technical & Regulatory Expertise

• Guide process chemistry, analytical development, and technology transfer teams.
• Ensure compliance with global regulatory standards (USFDA, EMA, PMDA, WHO, etc.).
• Support clients in regulatory submissions (DMFs, ANDAs, dossiers).

4. Operations & Supply Chain Management

• Drive operational excellence in API manufacturing facilities.
• Optimize plant capacity utilization, cost efficiency, and scalability.
• Collaborate with supply chain for raw material sourcing and vendor management.

5. Strategic & P&L Leadership

• Own P&L for the CDMO API vertical.
• Define growth roadmap, expansion strategy, and capacity investments.
• Monitor financial performance, margins, and new revenue streams.

Key Skills & Competencies:

• Strong knowledge of

  API development, scale-up, and commercial manufacturing

  .
• Deep understanding of

  global CDMO markets, client requirements, and regulatory pathways

  .
• Proven experience in

  business development, alliance management, and P&L leadership

  .
• Ability to lead cross-functional teams (R&D, QA, RA, Manufacturing, BD).
• Excellent negotiation, communication, and stakeholder management skills.

Experience

• 15-25 years of experience in the

  API / CDMO industry

  , with at least 5+ years in a leadership role.
• Track record of

  managing global clients and successful CDMO/API projects

  .
• Pharma Industry experience .
• US, Europe Market.

abhaya.chalurkar@cadilapharma.com .