Director, Product Sciences
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.
For more information, please visit: http://www.kitepharma.com/
Kite is seeking a highly motivated leader with cell culture experience to work on innovative T cell therapy for cancer treatment. The Director, Product Sciences will provide process development and engineering leadership for technology transfer, process validation and GMP manufacturing for Kite’s engineered autologous T cell therapy products. The Director, Product Sciences will manage a group responsible for manufacturing and development protocols, production procedures, and process development activities, 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 Director, Product Sciences 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 Director, Product Sciences will lead laboratory activities to support process development and process characterization of Kite’s autologous T cell products, as well as lead investigations into manufacturing non-conformances.
- Lead technology transfer and GMP manufacturing operations
- Act as technical expert to train and supervise process technicians
- Review and approve technical documentation (batch records, SOPs, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, and validation testing).
- Manage 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
- Must have 15+ years of pharmaceutical manufacturing, technology transfer & process development experience
- Ph.D in Biochemistry, Chemical Engineering, Biotechnology or equivalent
- Pharmaceutical products GMP manufacturing experience is a must
- Expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
- Mastery of scientific and engineering principles
- Practical experience in GMP operations
- Cell culture or aseptic processing experience is a plus
- Previous experience with cell therapy products 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
- Excellent interpersonal, verbal and written communication skills
- Ability to function efficiently and independently in a changing environment
- 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
- Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred; process validation experience is a plus
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.