Associate Director, Packaging and Labeling
Syndax Pharmaceuticals · New York, NY · 1 mo ago
RemoteRemoteArt & Creative$175k–$205k/yrFull-time
About the role
Syndax Pharmaceuticals is looking for an Associate Director, Packaging and Labeling. 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. Syndax’s corporate office is in New York, NY.
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.
Requirements
- 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.
Benefits
- Equity offering
- Annual target bonuses
- Outstanding benefits program
Pay
The anticipated annualized salary range for this role is $175,000 – $205,000.