Associate Director, Packaging & Labeling – Strategic Lead

Syndax Pharmaceuticals; New York (NY); On-site; USD 175,000 - 205,000; Full time

Job summary

Syndax Pharmaceuticals is seeking an Associate Director, Packaging & Labeling in New York to lead packaging, labeling, and production strategies across development through commercialization.

You will oversee multiple campaigns with CMOs, ensure regulatory and quality standards, and drive serialization and DSCSA compliance while collaborating with Regulatory Affairs, Quality, and Supply Chain.

Qualifications

• Bachelor’s degree in Packaging Science, Engineering, Supply Chain, Pharmaceutical Sciences, Life Sciences, Business, or related discipline.
• 8+ years of progressive experience in pharmaceutical packaging, labeling, external manufacturing, supply chain, manufacturing operations, or a related function.
• Demonstrated experience managing pharmaceutical packaging and labeling activities through development, regulatory approval, commercialization, and lifecycle management.
• Proven experience overseeing multiple concurrent production campaigns at CMOs, CDMOs, contract manufacturers, and/or contract packaging organizations.
• Strong understanding of external manufacturing operations, production scheduling, batch execution, packaging readiness, material planning, and product release processes.
• Experience with pharmaceutical serialization, DSCSA, GS1 standards, and 2D barcode requirements.
• Strong project management, organizational, communication, and problem-solving skills.
• Thrives in a fast-paced environment, able to effectively manage multiple activities and problem-solve to achieve business needs.
• Business travel, to various company offices, suppliers, and partners as required.

Responsibilities

• Provide end-to-end oversight and operational management of multiple concurrent pharmaceutical production and packaging campaigns at external manufacturers, CMOs, and contract packaging organizations.
• Monitor production progress and proactively identify risks related to scheduling, capacity, materials, quality, equipment, technical issues, and regulatory requirements.
• Drive resolution of production delays, deviations, quality events, material shortages, and other issues that may impact product supply.
• Escalate significant production, quality, supply, or compliance risks to senior leadership and develop appropriate mitigation and contingency plans.
• Lead the end-to-end development, review, approval, and implementation of pharmaceutical artwork and labeling.
• Provide packaging and labeling leadership for pharmaceutical serialization and traceability requirements.
• Support DSCSA requirements and serialized product traceability for U.S. commercial products, as applicable.
• Develop and maintain strong strategic relationships with contract packaging organizations, artwork agencies, printers, and packaging component suppliers.
• Identify and mitigate risks related to external manufacturing capacity, component shortages, supplier constraints, regulatory changes, production delays, and labeling implementation.
• Develop contingency plans for critical products, manufacturing sites, packaging components, and suppliers.

Skills

Packaging & Labeling

External manufacturing

Supply chain

Project management

DSCSA compliance

GS1 standards

2D barcodes

Education

Bachelor’s degree in Packaging/Engineering/Pharmaceutical Sciences

Job description

Syndax Pharmaceuticals is seeking an Associate Director, Packaging & Labeling in New York to lead packaging, labeling, and production strategies across development through commercialization.

You will oversee multiple campaigns with CMOs, ensure regulatory and quality standards, and drive serialization and DSCSA compliance while collaborating with Regulatory Affairs, Quality, and Supply Chain.