Senior Engineer II, Packaging Engineering – Kite Pharma Inc. – Santa Monica, CA, USA
Kite, a Gilead Company, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. 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 .
Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!
We are seeking a highly motivated individual to join the Packaging Engineering team as a Senior Engineer II. 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. The position will report to the Senior Manager of Packaging Engineering.
Responsibilities include but are not limited to:
- Utilize industry best practices to conduct the design, development, qualification, and implementation of packaging and labeling processes and shipping methods for temperature-controlled, sterile products
- Qualify shipping lanes and processes to ensure the safe delivery of life-saving therapies
- Support the design, qualification, and use of label printing and application equipment
- Maintain awareness of all government regulations as they pertain to packaging and labeling materials, components, processes, and products
- Investigate complaints/deviations and 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 and labeling components & methods
- Provide packaging and shipping expertise to support both internal and 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 and 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 8+ 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 and transport
- Cold Chain / Hazardous packaging and shipping experience strongly desired
- Knowledge of statistical methods and software desired