Senior Manager, Package Engineer – Kite Pharma, Inc. – Santa Monica, CA, USA
Kite Pharma Inc, founded in 2009, is a clinical 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 fight tumor cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced hematological and solid malignancies. We are rapidly growing with a highly energized and accomplished team that is science-based in focus while striving for flawless execution to provide commercially approved products to help patients fight cancer. Kite is publically traded, and our current market cap exceeds $2.5 billion dollars.
Essential Duties and Responsibilities:
- Utilize industry best practices to conduct the design, development, engineering, and implementation of packaging processes & shipping methods for temperature-controlled, sterile products
- Successfully operate in a fast paced and dynamic cross-functional environment
- Provide packaging & shipping expertise to support both internal & external logistics and supply chain partners
- Pursue goals & objectives utilizing standard Project management methods
- Maintain awareness of all government regulations as they pertain to packaging materials, components, processes, and products
- Investigate complaints & develop solutions for issues related to logistics, packaging (materials and design), and cold chain transport
- Write package material and component specifications, package Bill of Materials, and packaging process instructions for new and existing packaging.
- Review and approve packaging artwork and proofs for mechanical correctness.
- Plan, execute and document transit & distribution testing/qualification
- Transfer packaging & shipping items & solutions to both commercial & clinical environments
- Develop component cost estimates and other data, as required. Recommend economical alternatives consistent with high quality standards.
- Conduct Technical Risk Assessment for packaging & shipping methods
- Comply with the company change control procedures to ensure that only approved packaging materials and processes are used. Comply with all company procedures as required by the position.
- Identify alternate suppliers, as appropriate.
- 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 desired
- Knowledge of statistical methods and software
Kite Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Blvd and right off the 10. We are able to offer the opportunity to be part of the first 500 employees in this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation. Did we forget to mention the stock options? To learn more about us, please visit our website at www.kitepharma.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
No phone calls please and no agencies or recruiters.