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Principal Associate Scientist, Cell-Based Assays and Potency Testing

Seattle, WA

About GentiBio 

GentiBio is an emerging biotherapeutics company co-founded by pioneers in Treg biology and synthetic immunology from Seattle Children’s Research Institute, Benaroya Research Institute, and MIGAL Galilee Research Institute. GentiBio is focused on the development of EngTregs programmed to treat autoimmune, alloimmune, autoinflammatory and allergic diseases. GentiBio’s proprietary autologous and allogeneic EngTregs platform integrates key complementary technologies needed to successfully restore immune tolerance and overcome major limitations in existing regulatory T-cell therapeutics. 

GentiBio is seeking to build an organization with an exceptional company culture focused on empowerment, care for our team members, an appreciation for diversity and inclusion, and the development of our people. As such, we are looking for candidates who are not just great scientists and business professionals, but individuals who are looking to contribute to building and modeling an outstanding company culture – and having fun while doing so. 

GentiBio is building corporate operations in both Boston and Seattle. We are looking for outstanding leaders and scientists to join our team in both of our locations. 

Job Summary

GentiBio is seeking a self-driven, collaborative, results-oriented, and creative scientist to join our Analytical Development (AD) team in Seattle. The successful candidate will contribute to bioassay development for potency and characterization of our engineered regulatory T-cell (EngTreg) candidates. This lab-based role will establish functional and phenotypic methods that allow us to understand our drug products. The successful candidate will be part of the dynamic and motivated development team bringing GentiBio’s first EngTreg product to clinical trials. In addition, this role offers exposure to multiple facets of an organizational and company build, leadership, technological growth, and an ample opportunity to be a high-impact trailblazer in the emerging field of regulatory T-cell therapy.

Job Responsibilities

  • Foster the culture of seeking and giving help, inclusion, authenticity, and fun
  • Develop and optimize cell-based bioassays, potency tests, and characterization assays for cellular therapy product characterization; strategically build these assays so that they may be adapted for lot release in the future
  • Create method SOPs and support method qualification and documentation as appropriate per regulatory guidance
  • Partner with Process Development, Research, and Translational teams to align on the key EngTreg product attributes and best approaches to measure them
  • Collaborate with peers in Analytical Development to ensure that prioritized activities (i.e., method development, qualification, sample testing, etc.) are completed to a high standard and on time
  • Actively contribute with cross-functional teams by sharing technical expertise and experiences and effectively communicating results
  • Participate as a T cell biology expert in development or clinical investigations as needed
  • Collaborate with the Research team to ensure relevant product knowledge transfer to and from the Technical Development organization
  • Help build the cell therapy development laboratory from lab layout to mapping out of analytical workflows
  • Contribute technical expertise to new technology and due diligence efforts as needed
  • Support preparation of regulatory submissions and participate in their review

Qualifications and Education Requirements

  • B.S./M.S. in a relevant Science or Engineering discipline with 5+ years
  • Experience developing cell-based bioassays and potency methods for cell therapy products highly desired
  • Experience characterizing T-cell functionality with cell-based assays (LUMINEX, IncuCyte, flow cytometry) desired
  • Background in immunology and knowledge of T-cell and Treg biology strongly preferred
  • Knowledge of FDA, cGMP, and ICH regulatory requirements in the context of bioassay/potency assay development and qualification desired
  • Experience with statistical data analysis and mammalian gene editing systems preferred
  • Exceptional teamwork and communication skills
  • Flexibility to pivot from plan A to plan B
  • Ability to synthesize complex information and focus on key deliverable
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