About this opportunity
Oryon Cell Therapies lists this Senior Engineer / Principal Engineer, Process Development opportunity in boston, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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
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Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.