Bioengineer Senior Scientist Cell Therapy

Job Description

Company Description Tulynode Biosciences Inc. is a biotechnology company dedicated to addressing critical unmet needs in oncology by harnessing each patient’s own immune system. The company focuses on activating autologous immune cells that are specific to an individual’s tumor, aiming to deliver effective and safer cellular therapies with ex vivo manipulation. Tulynode’s gene modification strategy and “Immuno-Pod” platform is designed to expose otherwise inaccessible tumors in vivo, enhancing tumor-specific immune cell activation. This approach seamlessly integrates ex vivo and in vivo processes to create highly personalized, next-generation cancer treatments. Team members have the opportunity to contribute to innovative therapies at the intersection of immunology, gene modification, and oncology.

Role Description We are seeking a highly motivated and innovative Bioengineer to design, develop, and optimize cutting-edge biomedical devices and automated systems specifically tailored for Tumor-Infiltrating Lymphocyte (TIL) / T-cell therapies .

In this role, you will bridge the gap between discovery immunology and hardware engineering. Your primary focus will be designing tumor-tissue processors , closed-system bioreactors, microfluidic cell sorters, and fluid-handling automation systems to streamline the isolation, selection, genetic modification, and rapid expansion of patient-derived tumor-reactive T cells.

Key Responsibilities

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• Tumor tissue processor: Design and automate devices that can process tumor fragments and fine needle biopsies to generate uniform single cell suspensions.
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• Device & Bioreactor Design: Design, prototype, and test novel fluidic architectures, single-use consumables, and hardware platforms (e.g., perfusion bioreactors, closed-system cell sorters) to enable automated TIL isolation and expansion.
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• Automation & Process Integration: Streamline and automate critical unit operations—such as enzymatic tumor digestion, initial fragment outgrowths, specialized cell selection, expansion protocols, and automated washing/harvesting.
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• Microfluidics & Material Science: Apply microfluidic principles to optimize cell sorting and minimize shear stress on fragile, patient-derived T cells during processing. Evaluate biocompatibility of polymers and surface coatings to prevent non-specific cell adhesion.
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• Cross-Functional Collaboration: Partner directly with tumor immunologists, bioprocess scientists, and GMP manufacturing teams to translate bench-scale biology into robust, clinically viable, automated closed-loop devices.
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• Data-Driven Optimization: Utilize CAD modeling, computational fluid dynamics (CFD), and statistical software to simulate, evaluate, and refine device performance parameters (e.g., oxygen transfer rates, nutrient distribution, flow dynamics).
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• Regulatory Compliance & Documentation: Ensure hardware and software compliance with FDA guidelines for cell-therapy manufacturing equipment, including drafting comprehensive technical reports, Standard Operating Procedures (SOPs), and validation protocols (IQ/OQ/PQ).
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Qualifications

·       Education: Ph.D. in Bioengineering, Biomedical Engineering, Mechanical Engineering, or a closely related discipline.

·       Experience: 2–5+ years of experience in medical device development, ideally with a focus on cell and gene therapy (CGT) instrumentation, fluidics, or bioreactor design.

·       Technical Proficiencies:

·      Advanced proficiency in 3D CAD modeling software (SolidWorks, Autodesk Inventor) and simulation tools (COMSOL, ANSYS).

·      Hands-on experience with prototyping techniques (3D printing, CNC machining, injection molding).

·      Deep understanding of fluid dynamics in biological systems.

·      Familiarity with automated cell-processing platforms (e.g., Miltenyi CliniMACS Prodigy, rocking-bed bioreactors).

·       Biological Understanding: A foundational understanding of T-cell biology, cell culture mechanics, and the practical challenges associated with solid tumor processing and cell expansion. Experience with flowcytometry is desirable

·      Exceptional problem-solving capabilities, clear interdisciplinary communication skills, and a passionate, team-first approach to solving complex clinical manufacturing bottlenecks.

·      Experience designing disposable, single-use fluidic kits and gamma-irradiated consumables.

·      Knowledge of global regulatory frameworks for automated clinical manufacturing systems (e.g., ISO 13485, 21 CFR Part 11, cGMP requirements).

·      Experience integrating hardware with sensors (optical, pH, dissolved oxygen) and automation software (PLC programming, Python, or MATLAB).