Global External Manufacturing Leader

Syndax Pharmaceuticals; New York (NY); On-site; USD 270,000 - 290,000; Full time

Job summary

Syndax Pharmaceuticals seeks a Senior Director, External Manufacturing to lead the relationship with external CDMOs worldwide, ensuring compliant, cost-effective drug substance and drug product manufacturing for clinical and commercial programs.

The role reports to the Senior VP of Pharmaceutical Development and Manufacturing, guiding technology transfer, validation, and continued process verification while partnering with QA, Regulatory, and Finance to drive performance and risk management.

Qualifications

• Bachelor’s degree in a chemical/biological discipline is required.
• 15+ years of pharmaceutical/biotech manufacturing experience with outsourced partners.
• Experience leading governance for external CDMOs and global networks.
• Experience with tech transfer, validation, and continued process verification.
• Strong understanding of cGMP, quality systems, and regulatory readiness.

Responsibilities

• Own the operating relationship with CDMOs including governance and executive reviews.
• Provide day-to-day oversight of external manufacturing for clinical and commercial programs.
• Lead partner onboarding and integration with CMC, QA, Supply Chain, Regulatory, and Finance.
• Collaborate with substance and product leads on transfer, validation, and process verification.
• Drive readiness and performance across the external manufacturing network.
• Ensure operations comply with cGMP and quality standards.
• Monitor plans for schedule, capacity, yield, cost, and supply risk; resolve issues.
• Establish performance metrics for quality, delivery, and cost.

Skills

Executive leadership

External manufacturing governance

Cross-functional collaboration

Strategic thinking

Executive presence

Effective communication

Education

Bachelor’s degree in chemistry, chemical engineering, biochemistry, pharmaceutical sciences

Advanced degree or MBA preferred

Job description

Syndax Pharmaceuticals seeks a Senior Director, External Manufacturing to lead the relationship with external CDMOs worldwide, ensuring compliant, cost-effective drug substance and drug product manufacturing for clinical and commercial programs.

The role reports to the Senior VP of Pharmaceutical Development and Manufacturing, guiding technology transfer, validation, and continued process verification while partnering with QA, Regulatory, and Finance to drive performance and risk management.