BIOMEDICAL ENGINEER / SCIENTIST 3DBio Therapeutics is a biologics and bioprinting company with a focus on regenerative medicine that precision manufactures living tissues to allow the replacement of each individual patient's parts with tissues designed and created specifically for them. 3DBio has developed unique capabilities toward the creation of living tissue implants for therapeutic applications. The technology platforms include a full suite of features to meet the FDA's requirements for therapeutic manufacturing, including novel and proprietary: 3D-bioprinter (GMPrint™), bio-ink (ColVivo™), and cell processes. In pre-clinical studies, the platform has demonstrated the ability to generate functioning living tissues.

The BIOMEDICAL ENGINEER / SCIENTIST will be responsible for applying their knowledge of science and engineering to the design, development, and translation of biological products and technologies. They will work with other scientists and engineers in cross-functional project teams to research, design, and evaluate new technologies and products,

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RESPONSIBILITIES TO INCLUDE:

• Assists with exploratory research and the identification of new products.

• Helps develop formulations and characterizes the biological and mechanical properties of biomaterials.

• Prepares bio-ink components maintains cell cultures and produces tissue-engineered prototypes under aseptic and clean-room conditions.

• Aids in process development from benchtop research through clinical scale-up.

Supports product development in translating prototypes from bench-top to early in-vivo experiments to definitive animal testing including pharmacological and toxicological testing for regulatory submissions.

Help develop, set up, and validate data collection protocols for pre-clinical and benchtop data collections.

Participates in the experimental design and executes necessary experiments.

• Develops test protocols and test reports documenting the performance of prototypes at benchtop and in-vivo testing.
• Prepares materials for experiments including prototypes for testing.
• Performs data collection supporting test protocols.
• Performs data analysis on experimental results.

Drafts technical documents such as formalized test methods, study protocols and reports.

Assists in planning and execution of Safety and Performance testing of products consistent with varying levels of regulatory and pre-clinical/clinical requirements.

Presents their own work including interpretation of data and recommendations for next steps at internal meetings.

Perform and/or develop various analytic tests including but not limited to in vitro cell-based assays; ELISA assays, quantitative and potency (fluorescence, colorimetric, etc); Molecular biology (e.g. qPCR); Mechanical, Thermal, and Rheological testing.

May perform method validation and transfer activities.

Assists in any and all R&D activities across teams as necessary based on priorities and needs of the business.

JOB REQUIREMENTS

• Education: Bachelor of Science (BME or BS in relevant field)
• Essential Experience: 3-5 years in the development of implanted biological/medical products
• Experience in general wet lab technique
• Ideal – experience with tissues, cells, and materials of focus (e.g. cartilage, collagen, chondrocytes)
• Ability to work in a fast-paced environment both independently and in a group setting with minimal direction and the flexibility to adjust to workload based upon changing priorities.
• Strong critical and thinking and analytical skills
• Excellent interpersonal, verbal, and written communication skills
• Understands and applies basic principles of Design Controls is a plus