AstraZeneca · 21 hours ago
Process Engineer, Cell Therapy Process Development
US – Santa Monica Colorado Avenue – CA
Full-time
Onsite
Mid Level
$79K/yr - $119K/yr
3+ years expAstraZeneca is a leading pharmaceutical company seeking a highly motivated Process Engineer to support late-stage cell therapy process development and characterization activities. The role involves advancing cell therapy processes, performing data analysis, and collaborating across functions to ensure process alignment and readiness for commercial manufacturing.
BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
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
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
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
Qualification
Required
B.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 3+ years of hands‑on industry experience; OR M.S. with 2+ years; OR Ph.D. with 0 years of 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
Familiarity with automation platforms (e.g., CliniMACS Prodigy, Lovo, G-Rex, Wave bioreactors)
Experience implementing closed, automated, or high‑throughput systems
Experience designing and executing DOE and multivariate data analysis for cell therapy processes
Experience with JMP or similar statistical analysis tools
Formal training or demonstrated application of digitalization, automation, or AI‑enabled tools in bioprocess development
Benefits
Qualified retirement programs
Paid time off (i.e., vacation, holiday, and leaves)
Health, dental, and vision coverage in accordance with the terms of the applicable plans
Company
AstraZeneca
AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.
10001+ employees
H1B Sponsorship
AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (11)
Funding
Current Stage
Public CompanyTotal Funding
$5.26B2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B
2023-02-24Post Ipo Debt· $1.5B
Leadership Team
Pascal Soriot
Executive Director and Chief Executive Officer
Aradhana Sarin
Group CFO and Executive Director
Recent News
Essential Business
2026-01-24
2026-01-23
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