Process Engineer II (Cell Culture/Biotech)

dawarconsulting; Santa Monica (CA); On-site; USD 144,648,000 - 158,424,000; Full time

Benefits offered by this job

Medical

Paid Sick leave

401K

Job summary

Our client in Santa Monica, CA, seeks a Process Engineer II to support development, optimization, scale-up, and manufacturing of engineered T-cell therapy processes.

Role blends hands-on lab work with process development, statistical analysis, and technical documentation, supporting INDs, tech transfers, validation, and GMP clinical manufacturing.

Qualifications

• MS in Biochemical Engineering or Chemical Engineering, or related field with 0 years experience; OR BS in related engineering with 2 years pharma manufacturing/tech transfer experience.
• Hands-on cell culture and aseptic technique experience.
• Experience with media preparation, cell counting, reagents, and cryopreservation.
• Preferred: Cell therapy / T-cell manufacturing experience.
• Knowledge of immunology and T-cell biology.
• cGMP pharmaceutical manufacturing experience.
• Process development and DOE experience.
• Bioreactor experience.
• JMP or Minitab.
• Lean Six Sigma, statistical process control, and process data management.

Responsibilities

• Conduct hands-on cell culture, aseptic processing, and process development studies.
• Develop, optimize, characterize, and improve manufacturing processes for T-cell therapies.
• Design and execute process development studies and DOE/statistical analyses.
• Analyze and trend process performance and identify improvement opportunities.
• Support technology transfers, process validation, IND activities, and GMP clinical manufacturing.
• Develop/review SOPs, study plans, batch records, protocols, and technical reports.
• Provide process training for GMP clinical production.
• Collaborate with Research, Translational Medicine, Process Development, Manufacturing, and MSAT teams.
• Present study results and recommendations to technical and senior leadership.

Skills

Cell culture

Aseptic technique

DOE

Process development

Statistical analysis

Lean Six Sigma

Minitab/JMP

Education

MS in Biochemical Engineering

BS in related engineering

Tools

JMP

Minitab

Job description

Our client, a world leader in life sciences and biotechnology, is looking for a "Process Engineer II" based in Santa Monica, CA.

Job Duration: Long Term Contract (Possibility of Conversion to FTE)

Pay Rate : $51.25/hr on W2

Company Benefits:

• Medical
• Paid Sick leave
• 401K

Seeking a Process Engineer II to support the development, optimization, scale-up, and manufacturing of engineered T-cell therapy processes. The role combines hands-on laboratory work with process development, statistical analysis, technical documentation, and cross-functional collaboration supporting INDs, technology transfers, process validation, and GMP manufacturing.

Key Responsibilities

• Conduct hands-on cell culture, aseptic processing, and process development studies.
• Develop, optimize, characterize, and improve manufacturing processes for T-cell therapies.
• Design and execute process development studies and DOE/statistical analyses.
• Analyze and trend process performance and identify improvement opportunities.
• Support technology transfers, process validation, IND activities, and GMP clinical manufacturing.
• Develop/review SOPs, study plans, batch records, protocols, and technical reports.
• Provide process training for GMP clinical production.
• Collaborate with Research, Translational Medicine, Process Development, Manufacturing, and MSAT teams.
• Present study results and recommendations to technical and senior leadership.

Required Qualifications

• MS in Biochemical Engineering, Chemical Engineering, or related field + 0 years experience, OR BS in related engineering field + 2 years pharmaceutical manufacturing/process development/technology transfer experience.
• Hands-on cell culture and aseptic technique experience.
• Experience with media preparation, cell counting, reagents, and cryopreservation.
• Preferred Cell therapy / T-cell manufacturing experience.
• Knowledge of immunology and T-cell biology.
• cGMP pharmaceutical manufacturing experience.
• Process development and DOE experience.
• Bioreactor experience.
• JMP or Minitab.
• Lean Six Sigma, statistical process control, and process data management.