Manager, Labeling Operations
Kite Pharma
Summary
Kite Pharma, Inc. is an American biotechnology company specializing in cancer immunotherapy with a primary focus on genetically engineered autologous CAR T cell therapy. Founded in 2009 and headquartered in Santa Monica, California, Kite was acquired by Gilead Sciences in 2017 for $11.9 billion. The company develops cell-based therapies that reengineer a patient's own immune cells to attack and fight cancer cells, representing a personalized approach to cancer treatment. Kite's lead product, Yescarta (axicabtagene ciloleucel), was the first CAR T therapy approved by the FDA for treating adult patients with relapsed or refractory large B-cell lymphoma. With approximately 2,000 employees and manufacturing facilities in California, Maryland, and the Netherlands, Kite operates as an independent company within Gilead Sciences while maintaining its singular focus on advancing cell therapy to treat and potentially cure cancer. The company's innovative approach represents a paradigm shift in cancer treatment, moving away from traditional pharmaceutical manufacturing to individualized cell therapies created one patient at a time.
Job description
Key Responsibilities
- Manage commercial pharmaceutical labeling projects from initiation through implementation.
- Coordinate labeling activities across Regulatory Affairs, Quality Assurance, Supply Chain, Manufacturing, Packaging Engineering, and external vendors.
- Lead artwork development, review, approval, and implementation activities.
- Manage project timelines, risks, priorities, and deliverables to ensure on-time execution.
- Review and approve artwork proofs, printer proofs, and packaging components for accuracy and compliance.
- Maintain labeling documentation, specifications, change controls, and related controlled records.
- Identify and resolve labeling, artwork, and implementation issues.
- Support labeling systems, workflows, and continuous improvement initiatives.
Basic Qualifications
- BS/BA with 6+ years of relevant experience, or MS with 4+ years of relevant experience.
- Direct experience managing commercial pharmaceutical labeling projects.
- Experience with artwork development, artwork approval workflows, and labeling implementation.
- Experience reviewing printer proofs and packaging artwork.
- Strong understanding of commercial printing, packaging, and artwork production processes.
- Knowledge of GMP requirements and pharmaceutical labeling regulations.
- Experience working with cross-functional teams and external suppliers.
- Strong project management, organizational, and communication skills.
- Experience with document management, change control, and labeling systems.
Preferred Qualifications
- Experience supporting biologics, cell therapy, or specialty pharmaceutical products.
- Experience with Veeva Vault, GPLM, SmartSheet, or similar systems.
- PMP certification or formal project management training.
- Background in graphic arts, print production, packaging, or artwork management.
- Experience supporting global labeling operations.
Requirements
- BS/BA with 6+ years of relevant experience, or MS with 4+ years of relevant experience.
- Direct experience managing commercial pharmaceutical labeling projects.
- Experience with artwork development, artwork approval workflows, and labeling implementation.
- Experience reviewing printer proofs and packaging artwork.
- Strong understanding of commercial printing, packaging, and artwork production processes.
- Knowledge of GMP requirements and pharmaceutical labeling regulations.
- Experience working with cross-functional teams and external suppliers.
- Strong project management, organizational, and communication skills.
- Experience with document management, change control, and labeling systems.
Benefits
- Medical, Dental & Vision
- Life Insurance
- Paid Time Off
- Discretionary Annual Bonus
- Stock-Based Long-Term Incentives
Company overview
Kite Pharma, Inc. is an American biotechnology company specializing in cancer immunotherapy with a primary focus on genetically engineered autologous CAR T cell therapy. Founded in 2009 and headquartered in Santa Monica, California, Kite was acquired by Gilead Sciences in 2017 for $11.9 billion. The company develops cell-based therapies that reengineer a patient's own immune cells to attack and fight cancer cells, representing a personalized approach to cancer treatment. Kite's lead product, Yescarta (axicabtagene ciloleucel), was the first CAR T therapy approved by the FDA for treating adult patients with relapsed or refractory large B-cell lymphoma. With approximately 2,000 employees and manufacturing facilities in California, Maryland, and the Netherlands, Kite operates as an independent company within Gilead Sciences while maintaining its singular focus on advancing cell therapy to treat and potentially cure cancer. The company's innovative approach represents a paradigm shift in cancer treatment, moving away from traditional pharmaceutical manufacturing to individualized cell therapies created one patient at a time.