Process Engineer I, Process Design - Cell TherapyUnited States - California - Santa MonicaProcess/Product Development & OperationsRegular
***Bonus, Equity, Paid Shutdowns, 401k Match***
Kite is seeking a highly motivated and detail-oriented individual to work on innovative T cell therapies for cancer treatment. The Process Engineer I will be responsible for designing and executing experiments in the lab, help process development, process characterization, technology transfer activities, support or improve existing technologies, implement innovative solutions in commercial, and clinical manufacturing to advance Kite’s product portfolio. Additional responsibilities include analyzing and presenting experimental results, drafting / reviewing protocols, production procedures, and technical reports including documentation for regulatory filings. Process Engineer I will work on Autologous Process Design and Development within the Life Cycle Management Team.
- 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.
- Support development of 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.
- 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.
- MS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 0 to 1 year of experience or
- BS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 3+ years of experience or
- AS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 5+ years of experience or
- High School Diploma with 7+ years of experience or
- Established cell culture lab techniques and aseptic processing such as cell passaging, sampling, fluid handling, media formulation, managing reagents, and cryopreservation.
- Fundamental understanding of cell biology principles, sub-population types, differentiation, phenotype markers and metabolic pathways.
- 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.