Senior Engineer, Packaging
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.
We are seeking a highly motivated individual to join us as a Senior Packaging Engineer. As part of this role, the incumbent will support the design, development, and qualification of packaging materials along with the investigation of packaging/shipping deviations.
Responsibilities include but are not limited to:
- Utilize industry best practices to conduct the design, development, qualification, and implementation of packaging & labeling processes & shipping methods for temperature-controlled, sterile products
- Maintain awareness of all government regulations as they pertain to packaging & labeling materials, components, processes, and products
- Investigate complaints/deviations & develop solutions for issues related to logistics, packaging (materials and design), labeling and cold chain transport
- Write package material and component specifications, package Bill of Materials, and packaging process instructions for new and existing packaging
- Provide support for lifecycle management of cold chain packaging & labeling components & methods
- Provide packaging & shipping expertise to support both internal & external logistics and supply chain partners
- Comply with the company change control procedures to ensure that only approved packaging materials and processes are used
- Identify alternate suppliers, as appropriate
- Work closely with internal partners, Materials Management, Quality, and Manufacturing to provide packaging & labeling solutions
- Successfully operate in a fast paced and dynamic cross-functional environment
- Bachelor of Science Degree in Mechanical, Industrial, or Package Engineering and/or a related field
- Minimum 5 years of related experience
- Knowledge of 21 Code of Federal Regulations, cGMP’s, and other applicable FDA Regulatory requirements.
- Knowledge of U.S., Japanese, and European Compendia requirements as they pertain to packaging materials, components, processes, and products.
- Knowledge of pharmaceutical packaging & transport desired
- Cold Chain packaging experience
- Knowledge of statistical methods and software
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.