Senior Process Engineer, Autologous iPSC Therapy (GMP)

Oryon Cell Therapies; Boston (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Oryon Cell Therapies is seeking a Process Development Engineer to help build the manufacturing process for an autologous iPSC-derived dopaminergic neuron therapy. You will report to the CTO and work to increase process robustness, knowledge, and scale-up readiness across processing steps from starting material to cryopreservation.

The role spans reprogramming, iPSC expansion, directed differentiation, harvest, formulation, and device compatibility.

Qualifications

• BS, MS, or PhD in chemical engineering, biomedical engineering, bioengineering, 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; Harvest, formulation, cryopreservation; Process characterization and design of experiments; Technology transfer and GMP manufacturing support; Media and raw material development; Autologous or patient-specific process operations and scale-out; Process modeling, data systems, or PAT.

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

Skills

Process development

Cell therapy

DOE / statistics

Documentation

Technology transfer

GMP manufacturing experience

Education

BS/MS/PhD in relevant field

Tools

Process automation

Statistical analysis software

Job description

Oryon Cell Therapies is seeking a Process Development Engineer to help build the manufacturing process for an autologous iPSC-derived dopaminergic neuron therapy. You will report to the CTO and work to increase process robustness, knowledge, and scale-up readiness across processing steps from starting material to cryopreservation.

The role spans reprogramming, iPSC expansion, directed differentiation, harvest, formulation, and device compatibility.