Jobs in Gaithersburg, MD

About the role

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.

What you'll bring

• 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.
• 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 with JMP or similar statistical analysis tools.
• Formal training or demonstrated application of digitalization, automation, or AI‑enabled tools in bioprocess development.

Benefits