Process Development Engineer -Cell Therapy

Job Title: Process Engineer II – Cell Therapy Process Development

Location: Santa Monica, CA – Onsite 5 Days/Week

Schedule: Monday–Friday, 9:00 AM–5:00 PM; occasional weekends based on business needs

Duration: 12-Month Contract

Contract Type: Contract; potential for conversion based on business needs

Job Summary

Our client is seeking a highly motivated and detail-oriented Process Engineer II with hands-on process development experience to support innovative T-cell therapies for cancer treatment.

This position will be part of the Autologous Process Design and Development Life Cycle Management Team and will support process development, process characterization, technology transfer, and continuous improvement activities for cell therapy products.

The successful candidate will design and execute laboratory experiments, analyze and present data, support manufacturing process improvements, and develop technical documentation for clinical and commercial manufacturing.

Key Responsibilities

• Design and execute cell therapy process development experiments using automated platforms.
• Conduct laboratory studies to evaluate and implement new technologies, materials, and processes.
• Perform hands-on activities in a cell culture laboratory, including cell passaging, sampling, fluid handling, media preparation, reagent management, and cryopreservation.
• Support process and equipment characterization, performance monitoring, and trending.
• Develop and improve manufacturing equipment and systems for cell therapy products, including hardware, software, single-use components, and user requirements.
• Evaluate new technologies and materials for implementation into GMP manufacturing.
• Support technology transfer activities and GMP manufacturing operations.
• Provide process training to GMP manufacturing personnel.
• Apply Design of Experiments (DOE) and statistical analysis to support process development and optimization.
• Utilize tools such as JMP and/or Minitab for statistical analysis.
• Prepare and review protocols, SOPs, manufacturing batch records, technical reports, and summary reports.
• Analyze experimental data and communicate conclusions and recommendations to cross-functional teams.
• Create and present technical presentations and data summaries to project teams, senior leadership, and external collaborators.
• Troubleshoot process and equipment issues and recommend timely solutions.
• Collaborate with Research, Development, Manufacturing, Quality, and other cross-functional teams.
• Perform other duties as assigned.

Required Qualifications

• MS degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or related discipline with 2+ years of pharmaceutical/biotechnology manufacturing or process development experience; OR
• BS degree in a related engineering or biotechnology discipline with 4+ years of relevant experience; OR
• AS degree in a related discipline with 5+ years of relevant experience; OR
• High School diploma with 6+ years of pharmaceutical/biotechnology manufacturing or process development experience.

Required Experience

• Hands-on experience in cell therapy process development.
• Experience working with automated cell therapy/cell processing platforms.
• Hands-on cell culture and aseptic processing in an ISO 5 environment.
• Experience with cell passaging, sampling, fluid handling, media formulation, reagent management, and cryopreservation.
• Practical experience with bioreactors and bioprocess development.
• Experience designing and executing Design of Experiments (DOE).
• Working knowledge of statistical analysis and process data evaluation.
• Practical knowledge of cGMP manufacturing and applicable pharmaceutical/biotechnology regulations.
• Understanding of bioprocessing principles including scale-up/scale-out, hydrodynamics, mass transfer, and bioreactor design and monitoring.
• Understanding of cell biology, cell populations/subtypes, differentiation, phenotype markers, and metabolic pathways.
• Knowledge of material science and material compatibility for cell culture applications.
• Experience with biotechnology product manufacturing, aseptic processing, cell therapy, and process development.
• Strong troubleshooting, critical-thinking, and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work independently in a fast-paced and changing environment.
• Ability to collaborate effectively across Research, Development, Manufacturing, and other cross-functional teams.

Preferred Qualifications

• Experience with T-cell therapy or CAR-T manufacturing/process development.
• Experience with autologous cell therapy.
• Experience with automated cell processing technologies.
• Experience with flow cytometry.
• Experience with mRNA handling and processing.
• Experience with single-use technologies and disposable systems.
• Experience with JMP or Minitab.
• Experience supporting technology transfer into GMP manufacturing.

Work Environment

• 100% onsite in Santa Monica, CA
• Monday–Friday, 9:00 AM–5:00 PM
• Occasional weekend work may be required based on business needs.
• This is a 12-month contract position, with potential for conversion depending on business needs and performance.