Manager, Label Designing
Supply Chain | Santa Monica, CA | Full Time
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.
The Manager, Label Designing is responsible for the creation and management of graphic files for packaging & labeling components and package inserts using Adobe InDesign (or equivalent), coordinating the printing of these components and managing projects associated with the lifecycle management of Commercial labeling within Kite Pharma.
Responsibilities (include but are not limited to):
- Work with functional groups including Regulatory Affairs, Quality Assurance, Marketing, Legal, Packaging and Manufacturing to develop requirements for labeling text.
- Work with Marketing and Regulatory to develop and finalize content and product branding elements of packaging & labeling for US and ROW
- Obtain dielines from print suppliers for packaging components and package inserts.
- Using Adobe InDesign, transfer approved packaging text to dieline, add graphic elements and bar codes as required to packaging artwork.
- Coordinate test printing of any new components as required.
- Send artwork files to print suppliers after artwork is approved and print orders are placed.
- Obtain print proofs from print suppliers and route for approval.
- Attend press checks at print suppliers as needed for new printed items.
- Create illustrations and photographs as needed for package inserts.
- Provide technical drawings of packaging components for specification documents, SOPs and instruction documents as required.
- Create mock-ups as needed for regulatory and marketing purposes.
- Ensure artwork meets industry and regulatory standards for labeling
- Create, review and update SOPs as needed.
- Develop packaging & labeling processes and controls with a long term perspective for flexibility and growth
- Manage internal approval process of layouts, mockups, samples
- Work with Marketing and Regulatory to develop corporate identity for packaging materials.
- Work with Regulatory to create KITE package insert style guide.
- Work with Quality to qualify and onboard packaging & labeling suppliers
- Bachelor's Degree and 5 years relevant pharmaceutical experience.
- Proficient in MS Office and Adobe InDesign.
- Strong background with FDA cGMP standards and regulatory requirements for packaging and labeling.
- Able to quickly resolve issues and communicate to team members effectively.
- Excellent verbal, written, and interpersonal communication skills with internal and external customers.
- Ability to manage projects in a fast-paced launch environment.
Kite Pharma is an equal opportunity employer based in Santa Monica, CA. Kite Pharma offers the opportunity to be part of a successful, fast growing company in a cross functional and collaborative environment.
To learn more about us, please visit our website at www.kitepharma.com.
No phone calls please and no agencies or recruiters.