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Scientist/Engineer-Sr. Scientist/Sr. Engineer, Process Development

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 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/Engineer- Sr. Scientist/Sr. Engineer to join our Process Development (PD) team in Seattle in the role of a process development lead for GentiBio’s first engineered regulatory T-cells (EngTregs) program. This role offers exposure to multiple facets of an organizational and company build, leadership and technical 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 
  • Define and execute a process development technical plan (including proposed process design, unit operation parameters and technologies to be evaluated, and number of studies) that is in line with the overall CMC strategy and program timelines 
  • Work closely with the Analytical Development and Vector and Gene Editing leads to align on the drug product testing and gene delivery components of the PD strategy 
  • Oversee design, execution and documentation of PD studies  
  • Communicate the outcomes of the studies to cross-functional teams 
  • Author process development sections of regulatory filings 
  • Support process transfer activities to the clinical manufacturing site as well as any technical troubleshooting 
  • Collaborate with the Research team and academic collaborators to ensure relevant knowledge transfer to and from PD 
  • Contribute to the build of the cell therapy development laboratory from lab layout to mapping out of PD workflows 
  • Manage and mentor junior scientists 
  • Contribute technical expertise to new technology due diligence efforts as needed 

Qualifications and Education Requirements 

  • B.S./M.S. in a relevant Science or Engineering discipline with 8+ or Ph.D. with 2+ years of relevant experience
  • Experience in experimental design and development of cell therapy clinical manufacturing processes required  
  • Experience in T-cell process development and statistical data analysis, including the use of design of experiments (DOE) approaches, required  
  • Previous T-cell non-viral gene delivery and editing experience preferred 
  • Proficiency in R or Python preferred  
  • Understand of regulatory T cell biology and knowledge of T-cell cryobiology preferred but not required 
  • Experience with analytical methods (flow cytometry and molecular assays) and CMC regulatory filings preferred but not required 
  • Supervisory experience preferred but not required  
  • Exceptional teamwork and communication skills 
  • Flexibility to pivot from plan A to plan B 
  • Ability to synthesize complex information and focus on key deliverables  
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