3DBio Therapeutics is a biologics and bioprinting company with a focus on regenerative medicine that precision manufactures living tissues to allow 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 STAFF SCIENTIST will be responsible for the analytical development of assays to support the growth and advancement of 3D Bio's regenerative medicine products. The focus of the role is on the design and development of analytical and cell-based methods for the characterization of cellular therapeutics, to support process development and translational/clinical development.

RESPONSIBILITIES:

• Apply expertise in cell and/or molecular biology to analytical design and development of new analytical methods and standard procedures for cell therapy product characterization, ultimately supporting product development and quality control in CMC.
• Independently reviews existing process and analytical development and production data; designs and conducts necessary experiments; interprets results; recommends changes or additional experiments. Designs, executes, and interprets experiments to identify new methods to enhance the manufacture of or characterization of products in regards to safety, identity, strength, purity, stability and quality with minimal direction.
• Lead the technology transfer of analytical methods from development to QC and spearhead analytical method qualification and validation.
• Responsible for identifying and partnering with external CROs for assay design, and qualification and validation for external assays
• Work with regulatory to support IND filing for all assay related components of IND.

REQUIREMENTS:

• Education: PhD in Biochemistry, Biology or related field with relevant experience.
• Essential – experience with cell and protein assays
• Ideal – experience with tissues, cells, and materials of focus (e.g. cartilage, collagen, chondrocytes)
• Demonstrated strength in analytics and statistics
• Strong critical thinking skills
• Ability to plan and manage time across multiple priorities

To learn more about 3DBio, please visit our website: https://3dbiocorp.com/