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 technology platforms for the development of living tissue implants for therapeutic applications.

The Associate Director will refine and execute the strategy of cell sourcing and all cell related aspects of functional tissue engineering for 3D printing of organ/tissue therapeutics. Responsibilities include prioritizing and allocation of resources and overseeing the scientific infrastructure required to support all aspects of cell and cell process-related development for those products. Also, this role will participate in corporate initiatives including strategic partnering and business development activities as they relate to cell biology and cell sourcing activities.

Responsibilities:

  • Partner with cross-functional R&D leadership to develop therapies focused on 3D tissue-engineered organs/tissues for implantation
  • Lead development of robust cell expansion processes suitable for allogeneic or autologous products and appropriate documentation (e.g. SOPs, MBRs)
  • Develop and implement strategies for optimizing cell biology and function for three-dimensional cellular tissue-engineered therapeutics (organs/tissues)
  • Design and execution of all studies required to develop successful therapeutic designs including characterizing and understand the critical biology and function of the cells and cell-matrix interaction, the impact of donor-to-donor variability with regard to safety and efficacy and identify relevant biomarkers for desired potency and safety characteristics and to demonstrate product consistency
  • Development of all cell related assays internally and with external vendors as appropriate
  • Develop appropriate assay qualification procedures and manufacturing procedures to ensure process adherence
  • Plan effective strategies, develop efficient plans timelines and execute to meet program and corporate objectives
  • provide strategic and technical, cell biology leadership and guidance with a focus on product safety and efficacy
  • Supervise the design and execution of all studies necessary to qualify cell biology and manufacturing processes for FDA
  • Interact with and efficiently manage external collaborations if needed, tracking all
    activities and ensuring adherence to timelines and budget.
  • Partner with manufacturing to transfer research process and adapt as needed for technology transfer to and from external CMO and/or internal cell manufacturing suites in accordance with company strategy
  • Internally provide leadership and appropriate training for technicians to perform cell expansion processes
  • Evaluation of external cell sourcing opportunities, in-licensing opportunities and or strategic partnerships and initiatives related to cell biology and function.
  • Ensure provision of cells as needed for all ongoing development studies
  • Manage sourcing and storage of all tissue and cells for expansion and experiments
  • Build a highly effective and efficient scientific team through recruiting and developing talent in the group

Qualifications

  • PhD degree in Cell and/or Molecular Biology with -7-10 years of post-graduate experience in cellular therapy development with relevant roles in the industry.
  • An established technical leader with 3-5+ years of successful track record building and leading scientific teams that meet company goals and objectives in translating cell therapies to the clinic.
  • Thorough understanding of issues involved in manufacturing and process development of cell therapy products including extensive experience with mammalian cell culture at small and large scales (especially chondrocytes).
  • Strong experience in molecular and cellular biology, and biochemical and biological assay development
  • Excellent written and oral communication, time management, record keeping, and data analysis and outstanding collaborative skills

Preferred Skills

  • Thorough understanding of issues involved in manufacturing and process development of cell therapy products including extensive experience with mammalian cell culture at small and large scales (especially chondrocytes).
  • Strong experience in molecular and cellular biology, and biochemical and biological assay development
  • Excellent written and oral communication, time management, record keeping, and data analysis and outstanding collaborative skills