Process Engineer II

Job Title: Process Engineer II Location: Santa Monica, CA – Onsite 5 days/week Schedule: Monday–Friday, 9:00 AM–5:00 PM; occasional weekends based on business needs Contract Type: 12-month contract with potential for conversion based on business needsJob DescriptionKite is seeking a highly motivated and detail-oriented Process Engineer I or II with process development experience to support innovative T-cell therapies for cancer treatment. The Process Engineer will design and execute laboratory experiments, support process development and characterization, perform technology transfer activities, improve existing technologies, and implement innovative solutions for commercial and clinical manufacturing to advance Kite’s product portfolio. The role will also involve analyzing and presenting experimental results, drafting and reviewing protocols, production procedures, technical reports, and documentation supporting regulatory filings. The Process Engineer will work within the Autologous Process Design and Development function as part of the Life Cycle Management Team.Key ResponsibilitiesThe Process Engineer will conduct cell therapy process development experiments using automated platforms and design and execute laboratory studies supporting the evaluation, development, and implementation of new technologies and materials. The role requires hands-on work in a cell culture laboratory, including study design, experimental execution, data analysis, process analysis, and trending of process and equipment performance. The engineer will support the development of manufacturing equipment for cell therapy products, including hardware, software, single-use disposable components, and user requirements. The position will participate in evaluating new technologies and materials for introduction into GMP manufacturing, provide process training to GMP manufacturing personnel, and support technology transfer and GMP manufacturing operations as needed.The Process Engineer will perform statistical analysis using tools such as JMP and Minitab and apply Design of Experiments (DOE) methodologies as appropriate. Responsibilities also include writing and reviewing technical documentation, SOPs, draft manufacturing batch records, technical reports, and summary reports. The engineer will create and present data-driven presentations to communicate experimental results to stakeholders, cross-functional project teams, senior leadership, and external collaborators, while performing other duties as assigned.Education & ExperienceCandidates with an MS degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or a related discipline should have at least 2 years of pharmaceutical or biotechnology manufacturing and process development experience. Candidates with a BS degree should have 4+ years of relevant experience, candidates with an AS degree should have 5+ years, or candidates with a high school diploma should have 6+ years of pharmaceutical or biotechnology manufacturing and process development experience.Candidates should have experience working with automated cell therapy platforms and established cell culture laboratory techniques and aseptic processing in an ISO 5 environment, including cell passaging, sampling, fluid handling, media formulation, reagent management, and cryopreservation. Practical knowledge of cGMP manufacturing and applicable pharmaceutical and medical-device regulatory requirements is required. Hands-on process development experience, including the use of bioreactors and statistical Design of Experiments, is also required.The ideal candidate will demonstrate strong knowledge of scientific and engineering principles related to bioprocessing, including scale-up/scale-out approaches, hydrodynamics, mass transfer, and bioreactor design and monitoring. A fundamental understanding of cell biology, cell sub-populations, differentiation, phenotype markers, and metabolic pathways is expected, along with knowledge of material science and material compatibility for cell culture applications. Experience with pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development is highly desirable. Flow cytometry and mRNA handling/process knowledge are considered a plus.The successful candidate must be able to think critically, troubleshoot effectively, and solve problems in a timely manner. Excellent interpersonal, verbal, and written communication skills are required, along with the ability to work independently and efficiently in a changing environment. The candidate should be self-motivated, highly responsible, adaptable, and willing to take on responsibilities outside the initial scope of the position when required. Strong computer skills, a high level of energy, a positive attitude, and a results-oriented mindset are essential. The individual should be comfortable working in a fast-paced environment with minimal direction, adjusting priorities as business needs change, and collaborating effectively across research, development, and manufacturing teams.