Process Engineer, Cell Therapy Process Development

AstraZeneca•Gaithersburg, MD

1d•$81,000 - $122,000

About The Position

We are seeking a highly motivated Process Engineer to support late-stage cell therapy process development and characterization activities, including process development, process characterization, and BLA-enabling studies. The position focuses on cell therapy unit operations such as T-cell enrichment, activation, transduction, washes, and harvest using semi-automated or fully automated equipment. The ideal candidate has deep technical expertise and hands-on experience with cell therapy unit operations, with a record of supporting clinical and commercial readiness. The role includes optimizing and characterizing cell therapy processes, implementing closed-system operations and automation, analyzing process data, supporting GMP manufacturing readiness, and collaborating across technical and manufacturing teams. On-the-floor support may be needed during scale-up, engineering runs, PPQ batches, and commercial manufacturing campaigns, including off-shift support when required.

Requirements

M.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field with at least 2 years of industry experience; or B.S. with 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, and 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.

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, including DOE, multivariate studies, scale-down models, and scale-up assessments, in alignment with QbD and ICH guidelines.
Analyze data, write technical reports, and present study outcomes to cross-functional teams and governance forums.
Conduct batch record reviews, deviation assessments, 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.
Collaborate 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.