Global External Manufacturing Strategy Director

syndaxpharmaceuticals

New York (NY)

On-site

USD 210,000 - 280,000

Full time

6 days ago
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Job summary

Syndax Pharmaceuticals is seeking a Senior Director, External Manufacturing to lead the governance and operational oversight of Syndax's global CDMO network, ensuring reliable, compliant, and cost-effective drug substance and product manufacturing for clinical and commercial programs.

Reporting to the Senior Vice President, Pharmaceutical Development and Manufacturing, the role partners with CMC, Quality, Supply Chain, Regulatory, and Finance to manage technology transfer, validation, and

Qualifications

  • 15+ years of progressive pharmaceutical/biotech manufacturing experience.
  • Deep experience with small molecule API and oral solid dose manufacturing.
  • Experience launching new commercial products in the U.S. and international markets.
  • Experience managing multiple international CDMOs across regions/time zones.
  • Executive Director candidates should demonstrate broader network strategy and commercial accountability.
  • Strong understanding of global cGMP requirements and quality systems.

Responsibilities

  • Own governance and performance management of CDMOs and executive engagement.
  • Provide day-to-day operational oversight of external drug substance and drug product manufacturing.
  • Lead onboarding and integration of manufacturing partners across functions.
  • Coordinate technology transfer, validation, and continued process verification.
  • Ensure manufacturing operations meet cGMP and quality standards.
  • Monitor production plans, capacity, yield, cost, and supply performance.
  • Support regulatory filings, inspections, and lifecycle activities.

Skills

Leadership
Relationship management
Cross-functional collaboration
External manufacturing oversight

Education

Bachelor's degree in chemistry/chemical engineering/biochemistry/pharmaceutical sciences
Advanced degree or MBA preferred

Job description

Syndax Pharmaceuticals is seeking a Senior Director, External Manufacturing to lead the governance and operational oversight of Syndax's global CDMO network, ensuring reliable, compliant, and cost-effective drug substance and product manufacturing for clinical and commercial programs.

Reporting to the Senior Vice President, Pharmaceutical Development and Manufacturing, the role partners with CMC, Quality, Supply Chain, Regulatory, and Finance to manage technology transfer, validation, and

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