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 preclinical studies, the platform has demonstrated the ability to generate functioning living tissues and 3DBio is currently in clinical Phase 1/2a.

Job Description:

The Analytical Development Scientist will develop and provide technical support for analytical methods. To lead the transfer and qualification/validation activities associated with new and existing analytical methods for characterization and QC of our products. The role entails both lab-based activities and/or the on-site provision of technical leadership to third parties e.g. external GMP testing contract testing laboratories and external collaborators. The Analytical Development Scientist is responsible for the planning, coordination, and execution of experimental work; to investigate, optimize and improve analytical methods. The provision of technical support to GMP contract testing laboratories requires a working knowledge of GMP in addition to the technical knowledge of the analytical method.

Responsibilities:

  • Lead aspects of release testing and development of new/novel methods to support transfer and improvement activities. May take the lead as analytical SME in assay investigations from external parties.
  • Enable the Tech Transfer of analytical methods between functional groups either within or externally to/from third parties.
  • Plan and perform experimentation in accordance with procedures to support CMC activities.
  • Collate, analyze, conclude and present data and author/review/approve technical reports
  • Develop specifications for new analytical methods or as part of the life cycle management of existing products
  • Ensure that experimental work is recorded in appropriately controlled laboratory books or protocols in accordance with the requirements of GxP
  • Prepare, review and approve SOPs for analytical methods, assist in the preparation of training packages, and perform training.
  • Perform routine Development and/or QC analytical testing to support process development and GMP manufacturing activities.
  • Lead the preparation of experimental data for regulatory submissions and support the Regulatory Department in the preparation and review of regulatory documents
  • Acquire and maintain a broad knowledge of the science behind analytical methods for cell therapy.
  • Author GXP manufacturing documentation (e.g., analytical methods and qualification documents) as appropriate.
  • Own technical aspects of GMP investigations relating to analytical testing methods.
  • 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, quality control, 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 regard 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 labs for assay design, and qualification and validation for external assays.
  • Support internal QC and QC contract test laboratories in assay-related investigations.
  • Work with regulatory to support IND writing, review and update filing for all assay-related components of IND.

Skills and Competencies required:

  • Laboratory experience in multiple assay platforms; for example, HPLC, Flow cytometry, SDS Page, ELISA, PCR, automated counting and cell imaging.
  • Experience in the development, optimization, execution, and qualification of novel assays.
  • Analyze and interpret data generated using standard computer programs.

Requirements:

  • Education: PhD, MSc /BSc in Cell Biology, Biochemistry, or another relevant life science with relevant experience.
  • 5-10 years working in an analytical lab or similar scientific role
  • Essential – experience with cell and protein assays
  • Ideal – experience with tissues, cells, and materials of focus (e.g. cartilage, collagen, chondrocytes)
  • Investigate, optimize and improve analytical methods.
  • Requires working knowledge of GMP in addition to the technical knowledge of the analytical method