Process Engineer - Autologous Process Design

Job Description

***Bonus, Equity, Paid Shutdowns, 401k Match***

Kite is seeking a highly motivated individual who is detail-oriented and with materials assessment and technology development experience to work on innovative T cell therapies for cancer treatment.  As a Process Engineer I, you will be responsible for designing and executing engineering activities and lab studies in process development, technology evaluation, support of equipment qualification, process validation, and GMP manufacturing. Additional responsibilities include analyzing and presenting experimental results, drafting / reviewing protocols, production procedures, and technical reports including documentation for regulatory filings.  You will work within the Life Cycle Management Team within Autologous Process Design to design and scale-out cell therapy processes, evaluate new materials, implement innovative solutions in commercial and clinical manufacturing, and support or improve existing technologies to advance Kite’s product portfolio.  You will work closely with analytical, technology development, validation, manufacturing sciences, operations, business strategy, and external collaborators as needed to achieve the above objectives.                       

Key responsibilities:

• Design and execute laboratory studies that support the evaluation, development and implementation of new technologies and materials.    
• Perform hands-on lab-based activities in a cell culture lab, including conception of study designs and analysis of data
• Perform process or equipment analysis and trend process or equipment performance.
• Develop manufacturing equipment for cell therapy products including hardware, software, and single-use disposable design elements and user-requirements.
• Participate in the evaluation of new technologies and materials for introduction into GMP manufacturing
• Provide process training to GMP manufacturing personnel. 
• Support technology transfer and GMP manufacturing operations as needed.
• Perform statistical analysis including design of experiments (DOEs) as appropriate.
• Write and review technical documentation, technical SOPs, draft manufacturing batch records, technical reports and summary reports. 
• Support qualification, risk assessment, and validation activities as technologies advance closer to deployment at GMP clinical and/or commercial manufacturing.
• Create and present slides with supporting data to communicate results to stakeholders, cross-functional project teams, senior leadership or external collaborators. 
• Perform other duties as assigned.

Basic Qualifications:

• BS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 1+ years of experience or
• AS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 3+ years of experience or
• High School Diploma with 8+ years of experience or

Additional Qualifications:

• Established cell culture lab techniques and aseptic processing in an ISO 5 environment such as cell sampling, fluid handling, media formulation, managing reagents, and cryopreservation.
• Practical knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices.
• Practical demonstration of hands-on process development including use of bioreactors and use of statistical design of experiments is required.
• Mastery of scientific and engineering principles related to bioprocessing including scale-up / scale-out approaches, hydrodynamics, mass transfer, and bioreactor design and monitoring fundamentals. 
• Fundamental understanding of cell biology principles, sub-population types, differentiation, phenotype markers and metabolic pathways.
• Knowledge of material science and material compatibility for cell culture applications      
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development.
• Ability to think critically, troubleshoot, and problem solve in a timely manner.
• Excellent interpersonal, verbal and written communication skills are required.
• Ability to function efficiently and independently in a changing environment.
• Self-motivated, strong sense of responsibility, and willing to accept temporary responsibilities outside of initial job description.
• Well-developed computer skills.
• High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• Ability to work and collaborate in a fast pace dynamic cross-functional team setting across research, development, and manufacturing departments.