Syndax Pharmaceuticals

Senior Director, External Manufacturing

New York, NY, US$270,000-$290,000Posted 6 days ago

Job Description

Syndax Pharmaceuticals is looking for a

Senior Director, External Manufacturing

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role

Reporting to the Senior Vice President, Pharmaceutical Development and Manufacturing, the Senior Director, External Manufacturing will lead business relationship management and ongoing operational oversight of Syndax's global contract development and manufacturing organization network. Working across modalities, this role will ensure reliable, compliant, and cost-effective drug substance and drug product manufacturing for clinical and commercial programs. The role will partner closely with Chemistry, Manufacturing and Controls (CMC) technical leads on technology transfer, validation, and continued process verification, and Quality to support quality-system oversight, investigations, and corrective and preventive action follow-up.

Key Responsibilities

  • Own the operating relationship with contract development and manufacturing organizations (CDMOs), including governance, business reviews, performance management, issue escalation, and executive engagement.
  • Provide ongoing day-to-day operational oversight of external drug substance and drug product manufacturing for all clinical and commercial programs.
  • Lead identification, evaluation, selection, onboarding, and business integration of manufacturing partners in collaboration with CMC technical, Quality, Supply Chain, Regulatory, and Finance functions.
  • Partner with Drug Substance, Drug Product, and Analytical technical leads to ensure successful process development, technology transfer, validation, and continued process verification.
  • Drive CDMO contract development and manufacturing organization readiness, coordination, commitment, an

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