Cell Therapy Process Engineer II – GMP & Design

Spectraforce Technologies, Inc.; Santa Monica (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Spectraforce Technologies, Inc. is seeking a Process Engineer II in Santa Monica, CA to join the Process Design team.

You will provide hands-on lab support for studies supporting INDs, technology transfers, process validations, and GMP manufacturing of T cell therapy products. You will draft and review protocols, production procedures, and design reports while collaborating with a cross-functional team to scale cell therapy processes and advance the company product portfolio in a fast-paced

Qualifications

• MS degree in Biochemical Engineering, Chemical Engineering or related field with 0 years of pharmaceutical manufacturing experience required
• BS degree in Biochemical Engineering, Chemical Engineering or related field with 2 years of pharmaceutical manufacturing, technology transfer & process development experience required

Responsibilities

• Hands-on lab work and collaboration on process design studies to support process development, optimization, characterization, and essential process improvements
• Perform process training for GMP clinical production
• Participate in a cross-functional development team to advance CMC activities
• Perform process analysis and trend process performance
• Develop manufacturing processes for cell therapy products
• Design and execute process development studies to understand operating and performance parameters
• Perform statistical analysis, including design of experiments (DOEs) as appropriate
• Write and review technical documentation from SOPs, study plans, draft manufacturing batch records, technical reports, and summary reports
• Create slides and supporting data to communicate results to senior leadership
• Other collaboration and cross-functional activities as assigned

Skills

Cell culture

Aseptic technique

Critical thinking

Troubleshooting

Interpersonal communication

Cross-functional collaboration

Education

MS in Biochemical Engineering or Chemical Engineering

BS in Biochemical Engineering or Chemical Engineering with 2 years experience

Tools

JMP

Minitab

DOE

Job description

Spectraforce Technologies, Inc. is seeking a Process Engineer II in Santa Monica, CA to join the Process Design team.

You will provide hands-on lab support for studies supporting INDs, technology transfers, process validations, and GMP manufacturing of T cell therapy products. You will draft and review protocols, production procedures, and design reports while collaborating with a cross-functional team to scale cell therapy processes and advance the company product portfolio in a fast-paced