Cell Therapy Process Engineer II

Dawar Consulting; Santa Monica (CA); On-site; USD 69,000 - 74,000; Full time

Benefits offered by this job

Medical

Paid Sick Leave

401(k)

Job summary

Our client in Santa Monica, CA seeks a Manufacturing Engineer II to lead hands-on cell therapy process development and transfer to GMP manufacturing. You will work cross-functionally with R&D, Manufacturing, Quality, and Engineering to develop scalable, GMP‑compliant cell therapy processes.

The role focuses on process development, technology transfer, and implementation of new technologies for clinical and commercial manufacturing, with ISO 5 environment experience required.

Qualifications

• MS with 2+ years, BS with 4+ years, AS with 5+ years, or equivalent in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or 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.

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 DOE and statistical analysis using JMP, Minitab, or similar tools.
• Prepare and review protocols, SOPs, manufacturing batch records, technical reports, and regulatory-supporting documentation.

Skills

Cell culture

Aseptic processing

DOE & statistics

Scale-up/scale-out

Process development

Bioreactors

Education

MS in Biochemical/ Chemical/ Biomedical Eng

BS in Biochemical/ Chemical/ Biomedical Eng

AS in related engineering field

Tools

JMP

Minitab

Job description

Our client in Santa Monica, CA seeks a Manufacturing Engineer II to lead hands-on cell therapy process development and transfer to GMP manufacturing. You will work cross-functionally with R&D, Manufacturing, Quality, and Engineering to develop scalable, GMP‑compliant cell therapy processes.

The role focuses on process development, technology transfer, and implementation of new technologies for clinical and commercial manufacturing, with ISO 5 environment experience required.