Hybrid Cell Therapy Process Engineer – Late-Stage

AstraZeneca

Santa Monica (CA)

Hybrid

USD 81,000 - 122,000

Full time

3 days ago

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Job summary

AstraZeneca in Santa Monica, CA is seeking a Process Engineer to support late‑stage cell therapy process development and characterization, including unit operations such as T‑cell enrichment, activation, transduction, and harvest on semi‑ or fully automated systems.

You will design and execute DOE and multivariate studies, apply AI‑enabled analytics, and support PPQ, tech transfer, and manufacturing readiness. Requires MS with 2+ years or BS with 7+ years, GMP experience.

Qualifications

MS in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 2+ years of industry experience; OR B.S. with 7+ years of hands‑on industry experience.
Strong technical expertise in key cell therapy unit operations (e.g., cell isolation, activation, transduction, expansion, harvest, formulation, cryopreservation) or biologics.
Demonstrated experience with GMP operations and late‑stage / commercial readiness.
Proven ability to analyze complex datasets, develop sound recommendations, and communicate clearly across levels
Experience with late‑stage development and process characterization principles for cell therapy processes.
Demonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation.
Experience working in GMP environments, including batch record execution or review, deviations, and investigations.
Strong technical writing, data analysis, and problem‑solving skills.

Responsibilities

Process development and characterization
Design, execute, and support autologous or allogenic cell therapy process optimization and robustness studies.
Drive implementation of closed-system operations and automation strategies to support scalability and compliance.
Plan and execute process characterization studies (DOE, multivariate studies, scale‑down models, and scale‑up assessments) in alignment with QbD and ICH guidelines.
Perform data analysis, write technical reports, and present outcome of the studies to cross‑functional teams and governance forums.
Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes.
Apply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding.
PPQ, Tech Transfer & Manufacturing Readiness
Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required).
Support raw material risk assessments, comparability studies, and process risk evaluations across facilities and platforms.
Cross‑Functional Collaboration
Work closely with analytical sciences and manufacturing science and technology teams to ensure end‑to‑end process alignment.
Support lifecycle management, post‑approval changes, and continuous improvement initiatives for cell therapy processes.