Process Engineer, Cell Therapy Process Development
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
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.
Benefits
- Benefits offered include qualified retirement programs, paid time off (i.e. vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
