Process Engineer, Cell Therapy Process Development

AstraZeneca•Gaithersburg, MD

2d•$81,000 - $122,000

About The Position

We are seeking a highly motivated Process Engineer to support late-stage cell therapy process development, characterization, and BLA-enabling studies. The position focuses on cell therapy unit operations—including T-cell enrichment, activation, transduction, washes, and harvest—using semi-automated or fully automated equipment. The role requires deep technical expertise and hands-on experience supporting clinical and commercial readiness. The Process Engineer will develop and characterize processes, support scale-up and manufacturing readiness, and collaborate with analytical sciences and manufacturing science and technology teams. The position also supports lifecycle management, post-approval changes, and continuous improvement.

Requirements

Master’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field and at least 2 years of industry experience; or a bachelor’s degree and at least 7 years of hands-on industry experience.
Strong technical expertise in key cell therapy unit operations, such as cell isolation, activation, transduction, expansion, harvest, formulation, and cryopreservation, or in biologics.
Demonstrated experience with GMP operations and late-stage or commercial readiness.
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.
Proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation.
Experience in GMP environments, including batch record execution or review, deviations, and investigations.
Strong technical writing, data analysis, and problem-solving skills.

Nice To Haves

Familiarity with automation platforms such as CliniMACS Prodigy, Lovo, G-Rex, or 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.
Strong experimental design and execution skills.
Excellent cross-functional communication and collaboration.
Ability to work effectively in fast-paced, late-stage development environments.
Scientific curiosity, an ownership mindset, and willingness to support manufacturing operations.

Responsibilities

Design, execute, and support autologous or allogeneic 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, including DOE, multivariate studies, scale-down models, and scale-up assessments, aligned with QbD and ICH guidelines.
Analyze data, write technical reports, and present study outcomes to cross-functional teams and governance forums.
Conduct batch record review, deviation assessment, and data trending to ensure cell therapy manufacturing process robustness.
Apply AI-enabled tools and digital analytics to 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 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.