Process Engineer

The Fountain Group; Santa Monica (CA); On-site; USD 56,000 - 70,000; Full time

Job summary

The Fountain Group is seeking a Process Engineer for 100% onsite work in Santa Monica, CA. The role focuses on hands-on lab support for INDs, tech transfers, and GMP manufacturing of cell therapy products. You will draft procedures, design reports, and collaborate on process development to scale therapies.

Responsibilities include training for GMP clinical production, performing DOE and statistical analyses, and communicating results to senior leadership with supporting data.

Qualifications

• BS or MS in biochemical/chemical engineering required.
• Experience in pharmaceutical manufacturing, technology transfer and process development.

Responsibilities

• Provide hands-on lab support for studies supporting INDs, technology transfers, process validations, and GMP manufacturing for cell therapy products.
• Draft and review protocols, production procedures, and process design reports; design and scale cell therapy processes.
• Hands-on lab work and collaboration on process design studies to support development, optimization, characterization, and essential process improvements.
• Perform process training for GMP clinical production.
• Participate in cross-functional development teams 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 design of experiments (DOEs) and statistical analyses as appropriate.
• Write and review SOPs, study plans, batch records, technical reports, and summary reports.
• Create slides and supporting data to communicate results to senior leadership.

Skills

Lab support

Process design

Design of Experiments

Data analysis

Documentation

Cross-functional teamwork

Education

BS or MS in biochemical/chemical engineering

Job description

Process Engineer

Location: Santa Monica, CA.

Pay Range: $41 - 51/hr depending on experience

Contract: 1 year with possible extension and/or conversion

100% onsite in Santa Monica, CA. Non-local candidates must be willing to relocate at own expense.

Job Description

• Provide hands-on lab support for studies supporting new INDs, technology transfers, process validations, and GMP manufacturing for company engineered T cell therapy products.
• Draft and review protocols, production procedures, and process design reports. Work with a highly motivated team to design and scale cell therapy processes to advance product portfolio.
• 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 develop a thorough understanding of operating and performance parameters.
• Perform statistical analysis, including design of experiments (DOEs) as appropriate.
• Write and review technical documentation from writing technical SOPs, study plans, draft manufacturing batch records, technical reports, and summary reports.
• Create slides and supporting data to communicate results to senior leadership.

Qualifications

• BS or MS Degree in Biochemical Engineering, Chemical Engineering, or related discipline with experience inpharmaceutical manufacturing, technology transfer & process development