Process Development Associate

Process Development Associate

This role focuses on supporting the development, optimization, and scale-up of induced pluripotent stem cell (iPSC)-derived processes for advanced cellular therapies. You will perform aseptic cell culture, execute differentiation protocols, and contribute to process development studies that drive programs toward clinical and commercial manufacturing. Working in a highly collaborative environment, you will generate and analyze experimental data, support technology transfer activities, and help improve process robustness and reproducibility across research, development, and manufacturing operations.

• Perform aseptic cell culture and maintenance of iPSC-derived and other mammalian cell lines in a laboratory setting.
• Execute differentiation protocols to generate specific cell types from iPSC-derived lines according to established procedures.
• Support process development studies by planning, executing, and documenting experiments aimed at improving cell-based processes.
• Assist in scaling processes from small-scale laboratory formats to larger production formats, contributing to scale-up activities.
• Support process characterization and optimization efforts to enhance process robustness, consistency, and reproducibility.
• Generate, analyze, and interpret experimental data, and document results accurately in laboratory records and reports.
• Collaborate with cross-functional teams involved in process development, research, manufacturing, and technology transfer.
• Contribute to technology transfer activities by supporting the transfer of processes from development to manufacturing environments.
• Support troubleshooting of process deviations and technical challenges by identifying root causes and proposing solutions.
• Maintain accurate, complete, and compliant laboratory documentation, including notebooks, batch records, and electronic systems.
• Follow established standard operating procedures and laboratory best practices to ensure high-quality and consistent work.
• Participate in continuous improvement efforts within process development, including refinement of protocols and workflows.

• Bachelor's degree in Biology, Cell Biology, Biotechnology, Biochemistry, or a related Life Science field.
• 2–4+ years of hands-on aseptic cell culture experience.
• Experience working with mammalian cells in a laboratory setting.
• Experience with iPSC culture and differentiation.
• Experience performing qPCR and/or flow cytometry.
• Experience supporting process development, process optimization, or scale-up activities.
• Strong laboratory documentation skills, including accurate recording and organization of experimental data.
• Strong organizational skills with the ability to manage multiple experiments and tasks in parallel.
• Ability to follow detailed protocols and standard operating procedures in a regulated or structured environment.

• Master's degree in a scientific discipline.
• Experience with process development in biologics, cell therapy, or biotechnology environments.
• Exposure to technology transfer activities between development and manufacturing groups.
• Familiarity with GMP or GMP-like environments and expectations.
• Experience with flow cytometry data analysis and interpretation.
• Experience with qPCR assay setup, optimization, and data analysis.
• Interest in advanced iPSC technologies and cellular therapies.
• Strong communication skills and ability to collaborate effectively with cross-functional teams.
• Demonstrated ability to troubleshoot technical issues in cell culture and process development experiments.

This position is 100% onsite, working a Monday through Friday day shift schedule. You will work in a laboratory and process development environment focused on iPSC technology, cellular therapies, and process scale-up. The role offers direct exposure to process development, scale-up, and technology transfer activities, as well as broad interaction with research, development, and manufacturing operations. You will be part of a highly collaborative team with strong scientific mentorship and opportunities to contribute to programs advancing toward…