Develops, characterizes, optimizes, and scales cell therapy manufacturing processes for clinical and commercial production. Performs cell culture and aseptic processing in ISO 5 environments, evaluates equipment and technologies, analyzes process performance, troubleshoots issues, and supports technology transfer into GMP manufacturing. The role also applies DOE and statistical analysis and prepares protocols, SOPs, batch records, technical reports, and regulatory documentation.
Our client, a world leader in biotechnology and life sciences, is looking for a “Manufacturing Engineer II”.
Location: Santa Monica, CA
Job Duration: 12 Months - Contract To Hire
Rate: $50-$54.50/hr on W2
Company Benefits: Medical, Paid Sick Leave, 401 (k)
This role will focus on hands-on process development, process characterization, technology transfer, and implementation of new technologies for clinical and commercial manufacturing. The successful candidate will work cross-functionally with Research, Development, Manufacturing, Quality, and Engineering teams to develop robust, scalable, and GMP-compliant cell therapy processes.
Key Responsibilities
- Design and execute hands-on laboratory experiments for cell therapy process development, characterization, and optimization using automated platforms.
- Develop and evaluate cell culture processes, materials, technologies, and equipment for introduction into GMP manufacturing.
- Perform cell culture and aseptic processing activities in an ISO 5 environment, including cell passaging, sampling, fluid handling, media preparation, reagent management, and cryopreservation.
- Analyze and trend process and equipment performance; identify opportunities for process improvements and troubleshoot technical issues.
- Support development and implementation of cell therapy manufacturing equipment, including hardware, software, single-use systems, and user requirements.
- Support technology transfer, scale-up/scale-out, process implementation, and GMP manufacturing operations.
- Apply Design of Experiments (DOE) and statistical analysis using JMP, Minitab, or similar tools.
- Prepare and review protocols, SOPs, manufacturing batch records, technical reports, and regulatory-supporting documentation.
Required Qualifications & Experience
- MS with 2+ years, BS with 4+ years, AS with 5+ years, or equivalent experience in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or a related discipline.
- Experience in pharmaceutical/biotechnology manufacturing and process development.
- Hands-on experience with automated cell therapy platforms.
- Strong cell culture and aseptic processing experience in an ISO 5 environment.
- Practical knowledge of cGMP manufacturing and pharmaceutical/medical-device regulatory requirements.
- Hands-on process development experience with bioreactors, process monitoring, and DOE/statistical analysis.
- Understanding of bioprocess engineering principles including scale-up/scale-out, hydrodynamics, mass transfer, and bioreactor design
Preferred Qualifications
- Flow cytometry experience.
- mRNA handling and process development experience.
- Experience with automated cell therapy manufacturing platforms.
- Experience supporting technology transfer into GMP manufacturing.
- Experience with JMP, Minitab, or other statistical/process modeling tools.
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