Senior Engineer / Principal Engineer, Process Development

Position Summary

The Process Development Engineer will develop the manufacturing process for Oryon's autologous iPSC-derived dopaminergic neuron therapy. Reporting to the Chief Technical Officer, this individual will work to increase process robustness, build process knowledge, and prepare the manufacturing platform for commercial scale-out.

The process spans starting material processing, reprogramming, iPSC expansion, directed differentiation, harvest, formulation, and cryopreservation. Oryon is hiring process development engineers with complementary expertise across cell therapy CMC development, working closely with Product Sciences, Analytical Development, and our academic collaborators. Level will be determined by experience.

Key Responsibilities

• Develop and optimize unit operations across the process, with emphasis on process closure, simplification, and robustness against patient-derived starting material variability
• Execute technology transfer from academic collaborators into Oryon laboratories
• Develop the drug product process: formulation, fill, container closure, cryopreservation, and compatibility with the delivery device
• Identify and implement closed and automated systems suited to autologous scale-out, including evaluation of emerging technologies
• Define critical process parameters and acceptable ranges through structured experimental design, and execute process characterization
• Contribute to raw material and consumable strategy, including material grade and cost of goods optimization
• Support GMP process transfer, engineering runs, and manufacturing investigations
• Support authoring of process descriptions, batch records, transfer documentation, and process content for regulatory submissions
• Assist with laboratory build-out and support establishment of laboratory systems and workflows

Qualifications

Required

• BS, MS, or PhD in chemical engineering, biomedical engineering, bioengineering, cell biology, or related discipline
• Senior Engineer: 6\+ years (fewer with an advanced degree). Principal Engineer: 10\+ years, including ownership of a cell therapy process from development through technology transfer
• Experience taking a cell therapy process into GMP manufacturing
• Design of experiments and statistical analysis of process data
• Technical report writing and process documentation

Hands-on cell therapy process development experience, with depth in at least three of the following:

• Somatic cell reprogramming and iPSC expansion
• Directed differentiation of pluripotent stem cells to neural lineages
• Process closure and automation of cell culture and cell processing
• Harvest, formulation, cryopreservation, and container closure
• Process characterization and design of experiments
• Technology transfer and GMP manufacturing support
• Media and raw material development, and single-use consumable qualification
• Autologous or patient-specific process operations and scale-out
• Process modeling, data systems, or process analytical technology

Preferred

• Reprogramming and iPSC expansion depth
• Combination or device-delivered product experience
• Familiarity with automated cell processing platforms and digital tools for process data