Associate Director, Packaging and Labeling

<p><strong>Syndax Pharmaceuticals is looking for an <u>Associate Director, Packaging and Labeling</u></strong></p> <p>&nbsp;</p> <p>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.<strong>&nbsp;</strong></p> <p><strong>&nbsp;</strong></p> <p><strong>The Role:</strong><strong>&nbsp;</strong></p> <p>The Associate Director, Packaging &amp; Labeling provides strategic and operational leadership for pharmaceutical packaging, labeling, and production activities across the product lifecycle, from development and regulatory approval through commercialization and ongoing lifecycle management. This role is responsible for ensuring the timely, compliant, and efficient execution of commercial and clinical packaging and labeling operations, including the oversight and management of multiple concurrent production campaigns at contract packaging organizations. The candidate will coordinate closely with external manufacturing partners to ensure production schedules, packaging materials, artwork, batch documentation, quality requirements, and regulatory commitments are aligned and executed successfully.&nbsp;</p> <p>This position will partner closely with Regulatory Affairs, Quality, Supply Chain, Commercial, Clinical Operations, and external packaging partners to ensure reliable product supply while maintaining the highest standards of quality and compliance.<strong>&nbsp;</strong></p> <p><strong>&nbsp;</strong></p> <p><strong>Key Responsibilities:</strong><strong>&nbsp;</strong></p> <ul> <li>Provide end-to-end oversight and operational management of multiple concurrent pharmaceutical production and packaging campaigns at external manufacturers, CMOs, and contract packaging organizations.</li> <li>Monitor production progress and proactively identify risks related to scheduling, capacity, materials, quality, equipment, technical issues, and regulatory requirements.</li> <li>Drive resolution of production delays, deviations, quality events, material shortages, and other issues that may impact product supply.</li> <li>Escalate significant production, quality, supply, or compliance risks to senior leadership and develop appropriate mitigation and contingency plans.</li> <li>Lead the end-to-end development, review, approval, and implementation of pharmaceutical artwork and labeling.</li> <li>Provide packaging and labeling leadership for pharmaceutical serialization and traceability requirements.</li> <li>Support DSCSA requirements and