Senior Cell Therapy Process Engineer - Automation & Transfer

AstraZeneca plc; Santa Monica (CA); On-site; USD 96,000 - 144,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement programs

Job summary

AstraZeneca plc is seeking a Senior Process Engineer to advance late-stage cell therapy process development and characterization, including PPQ readiness and technology transfer to manufacturing sites.

You will work on unit operations such as T-cell enrichment, activation, transduction, washes, and harvest using semi-automated or automated equipment, with a focus on automation, QbD, and AI-enabled data analysis.

Qualifications

• Ph.D. or equivalent with multi-year industry experience in biotech.
• Experience with GMP operations and late-stage/commercial readiness.
• Strong data analysis and cross-functional communication skills.

Responsibilities

• Design, execute, and support autologous or allogenic cell therapy process optimization and robustness studies.
• Drive closed-system operations and automation for scalability and compliance.
• Plan and execute DOE, multivariate studies, and scale-up assessments per QbD/ICH.
• Prepare technical reports and present outcomes to cross-functional teams.
• Support control strategies, batch records, deviations, and data trending.
• Apply AI-enabled tools to accelerate data review and process understanding.
• Contribute to PPQ planning, readiness, and manufacturing transfer activities.

Skills

Cell isolation

Activation

Transduction

Expansion

Harvest

Formulation

GMP operations

Data analysis

AI tools & digital solutions

Education

Ph.D. in Chemical Engineering or Biochemical/biotechnology related field

M.S. in related field (with 5+ years) or B.S. with 7+ years industry experience

Tools

CliniMACS Prodigy

Lovo

G-Rex

Wave bioreactors

JMP

Job description

AstraZeneca plc is seeking a Senior Process Engineer to advance late-stage cell therapy process development and characterization, including PPQ readiness and technology transfer to manufacturing sites.

You will work on unit operations such as T-cell enrichment, activation, transduction, washes, and harvest using semi-automated or automated equipment, with a focus on automation, QbD, and AI-enabled data analysis.