Manager, Labeling Operations

Kite Pharma, Inc.; Santa Monica (CA); Hybrid; USD 124,000 - 160,000; Full time

Job summary

Kite Pharma, Inc. in Santa Monica, CA is seeking a Manager, Labeling Operations to lead commercial labeling projects from initiation to implementation.

You will coordinate labeling activities across Regulatory Affairs, Quality Assurance, Supply Chain, Manufacturing, Packaging Engineering, and external vendors to ensure on-time delivery. The role requires strong project management, cross-functional collaboration, and deep knowledge of GMP labeling regulations and artwork workflows.

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.
• Knowledge of GMP requirements and pharmaceutical labeling regulations.

Responsibilities

• Manage commercial pharmaceutical labeling projects from initiation through implementation.
• Coordinate labeling activities across Regulatory Affairs, QA, 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.

Skills

Project management

Cross-functional collaboration

Regulatory labeling knowledge

GMP knowledge

Packaging/artwork understanding

Documentation control

Communication skills

Education

BS/BA in related field

MS in related field

Tools

Veeva Vault

GPLM

SmartSheet

Job description

## Manager, Labeling OperationsApply: Onsite - Hybrid Eligible: United States - California - Santa Monica: Full time: Posted Yesterday: R0054733We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.## 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.The salary range for this position is: $123,930.00 - $160,380.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans\\*.For additional benefits information, visit:https://www.gilead.com/careers/compensation-benefits-and-wellbeing\\* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.