Senior Process Engineer/Scientist
Product Sciences | Santa Monica, CA | Full Time
Kite Pharma Inc, founded in 2009, is dedicated to 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. We are a small, dynamic and accomplished team with an exciting growth trajectory for the coming year.
Kite is seeking a highly motivated individual with cell culture experience to work on innovative T cell therapy for cancer treatment. The Senior Process Engineer will provide process development and engineering support for technology transfer, process validation and GMP manufacturing for Kite’s engineered autologous T cell therapy products. The Senior Process Engineer will 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 Senior Process Engineer will work with the Product Sciences team to design and scale-out 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 Senior 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 limited to):
- Manage technology transfer and oversee 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)
- Participate and report to a cross-functional development team to advance production activities
- Develop manufacturing processes for cell therapy products and develop process improvements and efficiencies
- Perform hands-on activities that support process development and process characterization, ranging from drafting procedures to execution of laboratory studies
- Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
- Design and execute process development studies to develop a thorough understanding of operating and performance parameters
- Other duties as assigned
- Must have 5+ years of pharmaceutical manufacturing, technology transfer & process development experience
- A degree in Biochemistry, Chemical Engineering, Biotechnology or equivalent
- Fluency with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
- Working knowledge of scientific and engineering principles
- Practical experience in GMP operations
- Pharmaceutical products GMP manufacturing experience
- 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
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development
- Ability to think critically, and demonstrated troubleshooting and problem solving skills
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Read and interpret drawings such as blueprints, AutoCAD, P&ID, PLC
- Well-developed computer 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 Boulevard and right off the 10 Freeway. We are able to offer the upside of working in a small, but growing company where everyone knows your name and respects your opinion while at the same time offering top-notch benefits. 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.