Cell Therapy Process Engineer – Late-Stage & Automation

AstraZeneca; Gaithersburg (MD); On-site; USD 81,000 - 122,000; Full time

Benefits offered by this job

Short-term incentive bonuses

Equity-based awards

Retirement programs

Paid time off

Health, dental, and vision coverage

Job summary

AstraZeneca is seeking a Process Engineer to support late-stage cell therapy process development and characterization, including unit operations like enrichment, activation, transduction, and harvest using semi-automated or automated systems.

You will drive closed-system operations, automate workflows, and perform DOE-based studies under QbD/ICH guidelines, with cross-functional collaboration to enable clinical and commercial readiness.

Qualifications

• M.S./B.S. with relevant industry experience in cell therapy.
• Experience with GMP operations and late-stage / commercial readiness.
• Strong data analysis, clear cross-level communication.
• Experience with DOE and multivariate data analysis for bioprocesses.

Responsibilities

• Design, execute, and support autologous or allogenic cell therapy process optimization and robustness studies.
• Drive closed-system operations and automation for scalability.
• Plan and execute DOE and multivariate studies per QbD and ICH guidelines.
• Perform data analysis, write technical reports, and present results to cross-functional teams.
• Conduct batch record reviews, deviation assessments, and data trending for robustness.
• Apply AI-enabled tools and digital analytics to data review and process understanding.
• Provide on-the-floor technical support during scale-up and PPQ batches.
• Support risk assessments and comparability studies across facilities.

Skills

Cell therapy unit operations

GMP operations

Data analysis

AI tools & digital solutions

Technical writing

Education

M.S. in Chemical/Biochemical Engineering or Biotechnology

B.S. with 7+ years of hands-on industry experience

Tools

CliniMACS Prodigy

Lovo

G-Rex

Wave bioreactors

Job description

AstraZeneca is seeking a Process Engineer to support late-stage cell therapy process development and characterization, including unit operations like enrichment, activation, transduction, and harvest using semi-automated or automated systems.

You will drive closed-system operations, automate workflows, and perform DOE-based studies under QbD/ICH guidelines, with cross-functional collaboration to enable clinical and commercial readiness.