Autologous Cell Therapy Process Engineer

Cube Hub Inc.; Santa Monica (CA); On-site; USD 90,000 - 140,000; Full time

Job summary

Cube Hub Inc. in Santa Monica, CA is seeking a Process Engineer (Autologous Cell Therapy) to design and execute laboratory studies for cell therapy process development.

The role involves working on autologous design and development within the Life Cycle Management Team, transferring technologies to GMP manufacturing, and delivering technical reports for regulatory filings. The position requires hands-on lab experience, knowledge of cGMP, and the ability to analyze data and present results to

Qualifications

• 2+ years of experience in process development for cell therapy (MS/BS/AS route)
• Experience with automated platforms and aseptic processing in GMP settings

Responsibilities

• Conduct cell therapy process development experiments using automated platforms.
• Design and execute laboratory studies to evaluate new technologies and materials.
• Perform hands-on lab-based activities in a cell culture lab in GMP environment.
• Develop manufacturing equipment for cell therapy products including hardware and disposables.
• Support technology transfer and GMP manufacturing operations as needed.
• Write and review technical documentation and batch records.
• Communicate results to stakeholders and cross-functional teams.

Skills

Automated cell therapy platforms

Cell culture techniques

cGMP manufacturing

DOE / design of experiments

Statistical analysis (JMP/Minitab)

Cross-functional collaboration

Education

MS in Biochemical/ Chemical/ Biomedical Engineering or related

BS in Biochemical/ Chemical/ Biomedical Engineering or related

AS in Biochemical/ Chemical/ Biomedical Engineering or related

High School diploma with 6+ years pharma/biotech exp

Tools

JMP

Minitab

Bioreactors

Job description

Cube Hub Inc. in Santa Monica, CA is seeking a Process Engineer (Autologous Cell Therapy) to design and execute laboratory studies for cell therapy process development.

The role involves working on autologous design and development within the Life Cycle Management Team, transferring technologies to GMP manufacturing, and delivering technical reports for regulatory filings. The position requires hands-on lab experience, knowledge of cGMP, and the ability to analyze data and present results to