Process Engineer, Cell Therapy Process Development

Position Summary

We are seeking a highly motivated Process Engineer to support late-stage cell therapy process development and characterization activities. In this role, you will play critical role in advancing late-stage cell therapy process development, process characterization, and BLA‑enabling studies.

This position focuses specifically on cell therapy unit operations, including T-cell enrichment, activation, transduction, washes and harvest either semi-automated or fully automated equipment.

The ideal candidate brings deep technical expertise, hands-on experience with cell therapy unit operations, and demonstrates success in supporting clinical and commercial readiness.

Key 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.

Required Qualifications

• M.S. 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.

Preferred Qualifications

• 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.

Key Competenc