Principal Process Engineer
Product Sciences | Santa Monica, CA | Full Time
Kite Pharma, Inc. is focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to eradicate cancer cells. We believe our immunotherapy is a market-redefining approach to the treatment of cancer. We are an innovative and growing company located in beautiful Santa Monica and have a highly energized and accomplished team. We had one of the most successful biotechnology IPOs in 2014 and have a current market capitalization of well over $2 billion (NASDAQ: KITE).
Kite is seeking a highly motivated individual with cell culture experience to work on innovative T cell therapy for cancer treatment. The Principal Process Engineer will provide process development and engineering support for product development, technology transfer, process validation and GMP manufacturing for Kite’s engineered autologous T cell therapy products. The Principal Process Engineer will design and implement new processes; draft and review protocols, production procedures, and process development reports; and provide technical assessment and approval for engineering and process changes as well as documentation pertaining to process development, qualification, and validation to meet regulatory requirements. The Principal Process Engineer will work with the Product Sciences team to design cell therapy processes, manage equipment qualification and support process validation, as well as draft documentation for regulatory filings to advance Kite’s product portfolio. The Principal Process Engineer will also participate in laboratory activities to support process development and process characterization of Kite’s autologous T cell products.
Responsibilities include, but are not limited to:
- Develop manufacturing processes and process improvements for cell therapy products
- Manage technology transfer and support GMP manufacturing operations
- Act as technical expert to train and supervise process technicians
- Write and review technical documentation (batch records, SOPs, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, and validation testing)
- Work with a cross-functional development team to advance production activities
- Design and perform process development and process characterization studies, generate technical reports supported by statistical analysis of results and lead implementation of process improvements
- Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
- Other duties as assigned
- A degree in Chemistry, Biochemistry, Chemical Engineering, Biotechnology or related discipline with at least 10 years of pharmaceutical manufacturing, technology transfer & process development experience
- Fluency with cGMP manufacturing and regulatory regulations for biologics, and requirements for pharmaceuticals and devices
- Excellent understanding of DOEs and statistical analysis
- Working knowledge of scientific and engineering principles
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development
- Proven experience of using statistical software like JMP or Minitab
- Ability to think critically, and demonstrated troubleshooting and problem solving skills
- Read and interpret drawings such as blueprints, AutoCAD, P&ID, PLC
- Well-developed computer skills
- Pharmaceutical products GMP manufacturing experience is a must
- Cell culture or aseptic processing experience is a plus
- Previous experience with cell therapy products is a plus
- Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred; process validation experience is a plus
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Excellent skill in Microsoft word, Excel and data analysis
- Strong organizational and record keeping skills
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
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 200 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.