Catalyst Pharmaceuticals, Inc. · 1 day ago
Artwork and Packaging Manager
Coral Gables, FL
Full-time
Onsite
Senior Level, Lead/Staff
$152K/yr - $162K/yr
8+ years expCatalyst Pharmaceuticals, Inc. is dedicated to improving the lives of patients with rare diseases, and they are seeking an Artwork and Packaging Manager to oversee artwork, labeling, and packaging processes for their products. This role involves ensuring compliance with regulatory requirements and managing cross-functional collaboration to support packaging operations.
BiotechnologyHealth CareHealth DiagnosticsPharmaceutical
Responsibilities
Support and manage Catalyst’s established artwork and labeling processes and systems, ensuring consistent and compliant execution
Manage commercial and clinical artwork/labeling changes from initiation through implementation, including coordination of cross-functional reviews and approvals
Ensure all artwork and labeling content complies with applicable pharmaceutical regulatory requirements for relevant markets (e.g., FDA, EMA, and other global authorities as applicable)
Maintain oversight of label inventory and version control, ensuring correct versions are used and obsolete materials are properly managed
Support complex labeling and packaging changes, including those driven by regulatory updates, safety changes, product lifecycle updates, or operational improvements
Provide artwork and labeling support for Marketing initiatives and for Regulatory Affairs, ensuring promotional and commercial needs align with regulatory and quality requirements
Demonstrated ability to work independently and lead artwork-related change activities
Support packaging operations across commercial and clinical supply, acting as a technical resource for packaging-related activities
Manage packaging component inventory, including specifications, lifecycle status, and coordination with Supply Chain and vendors
Oversee packaging vendor management, serving as a primary point of contact for artwork, labeling, and packaging-related execution
Support and assess packaging vendor equipment changes or upgrades, ensuring compatibility with Catalyst packaging requirements and regulatory expectations
Apply hands-on knowledge of packaging systems and equipment to troubleshoot issues, support process improvements, and enable successful change implementation
Qualification
Required
Bachelor's degree in engineering, Packaging Science, Life Sciences, or a related field
Minimum of 8 years of experience working within pharmaceutical artwork, labeling, and packaging operations within a regulated environment
Demonstrated experience managing commercial and clinical artwork and labeling in a regulated environment
Hands-on experience with pharmaceutical packaging systems and equipment
Strong understanding of change management, version control, and packaging lifecycle management
Ability to manage multiple projects simultaneously in a fast-paced, highly regulated environment
Preferred
Experience working with CMOs, external packaging vendors and artwork vendors
Familiarity with electronic artwork management systems (such as Manage Artworks) and document control tools
Prior experience supporting regulatory inspections or audits related to packaging and labeling
Benefits
Health, dental, and vision insurance
Generous paid time off
A retirement savings plan with Company Match
Company
Catalyst Pharmaceuticals, Inc.
Catalyst Pharmaceuticals, Inc., (Nasdaq: CPRX) is a biopharmaceutical company committed to improving the lives of patients with rare diseases.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$273.94M2024-01-05Post Ipo Equity· $140.1M
2017-11-27Post Ipo Equity· $53.6M
2015-02-03Post Ipo Equity· $34.7M
Leadership Team
Hubert E. Huckel
Co-Founder & Board of Directors
Michael W. Kalb
EVP & Chief Financial Officer
Recent News
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