Associate Director, Packaging and Labeling

The Role:

The Associate Director, Packaging & 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.

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.

Key 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.

Desired Experience/Education and Personal Attributes:

• 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.

Location: Syndax's corporate office is in New York, NY.

Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $175,000 - $205,000.

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