Process Engineer I/II - Cell Therapy Process Development

Process Engineer I/II – Cell Therapy Process Development
Location: Santa Monica, CA
Pay Rate: $56.68/hr
Employment Type: Contract (via ATR International)

About the Role

Our client, a leader in cell and gene therapy, is seeking a highly motivated and detail-oriented Process Engineer I/II to join their Autologous Process Design and Development team within Life Cycle Management. This role supports the development of innovative T cell therapies for cancer treatment — designing and executing lab experiments, driving process development and characterization, supporting technology transfer, and implementing innovative solutions across clinical and commercial manufacturing.

Key Responsibilities

• Conduct cell therapy process development experiments using automated platforms
• Design and execute laboratory studies supporting evaluation, development, and implementation of new technologies and materials
• Perform hands-on lab activities in a cell culture lab, including study design and data analysis
• Analyze and trend process/equipment performance
• Develop manufacturing equipment for cell therapy products, including hardware, software, and single-use disposable design elements and user requirements
• Evaluate 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 (JMP, Minitab) and design of experiments (DOEs) as appropriate
• Write and review technical documentation, SOPs, batch records, and technical/summary reports
• Create and present data-driven slides to stakeholders, cross-functional teams, senior leadership, and external collaborators
• Perform other duties as assigned

Required Experience

• Hands-on experience with automated cell therapy platforms
• Established cell culture lab technique and aseptic processing in an ISO 5 environment (passaging, sampling, fluid handling, media formulation, reagent management, cryopreservation)
• Practical knowledge of cGMP manufacturing and pharmaceutical/device regulatory requirements
• Hands-on process development experience including bioreactors and statistical DOE
• Strong grasp of bioprocessing engineering principles: scale-up/scale-out, hydrodynamics, mass transfer, bioreactor design and monitoring
• Foundational understanding of cell biology (sub-populations, differentiation, phenotype markers, metabolic pathways)
• Knowledge of material science/compatibility for cell culture applications
• Demonstrated experience in biotech manufacturing, aseptic processing, cell therapy products, and process development
• Strong critical thinking, troubleshooting, and problem-solving skills
• Excellent verbal and written communication skills
• Ability to work independently in a fast-paced, dynamic, cross-functional environment
• Self-motivated with a strong sense of ownership; flexible to shifting priorities and scope
• Flow cytometry knowledge a plus
• mRNA handling/process knowledge a plus

Education & Experience

• MS in Biochemical, Chemical, or Biomedical Engineering, Biotechnology, or related field + 2 years' relevant pharma/biotech experience, OR
• BS in same fields + 4 years' relevant experience, OR
• AS in same fields + 5 years' relevant experience, OR
• High School diploma + 6 years' pharma/biotech manufacturing & process development experience

ATR International is a staffing and workforce solutions firm providing high‐quality talent across a wide range of industries, including technology, operations, and professional services.