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Associate Director, Product Characterization and Product Sciences

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 Associate Director to join our Analytical Development (AD) team in Seattle. The ideal candidate will support GentiBio’s first engineered regulatory T-cells (EngTregs) program. As the Head of Product Characterization and Product Sciences, the successful candidate will provide strategic leadership for defining the product characterization strategy and help drive data-based decisions to optimize product quality. This role offers exposure to multiple facets of an organizational and company build, leadership and 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 
  • Own the definition of EngTreg target drug product profile and product characterization strategy 
  • Manage a team of scientists who will be designing cutting-edge functional and phenotypic characterization methods 
  • Guide development of cell-based drug product characterization methods  
  • Oversee characterization testing of development and clinical drug product lots and own the correlative analysis of the data against clinical outcomes  
  • Partner closely with Research and Translational teams to align on the key EngTreg product attributes and best approaches to measuring them  
  • Partner closely with Process Development to align on key EngTreg product attributes that effectively inform process decisions 
  • Provide technical leadership with cross-functional teams by sharing expertise and experiences and effectively communicating results  
  • Lay the groundwork for an effective potency release testing strategy 
  • Collaborate with peers in Analytical Development to develop and execute a drug product stability strategy  
  • Contribute content to regulatory filings   
  • Participate as a Treg biology expert in development or clinical investigations as needed  
  • Collaborate with the Research team and the academic collaborators to ensure relevant product knowledge transfer to and from 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 

Qualifications and Education Requirements  

  • PhD in Immunology, Cell Biology, or equivalent discipline with 8-12 years of characterization experience of T-cell products, with at least 4 of those years in an industry setting 
  • Expertise in Treg biology and experience with the development of T-cell characterization methods required  
  • Supervisory experience (3-5 years) required 
  • Experience with statistical data analysis and mammalian gene editing systems preferred  
  • Experience with CMC regulatory filings 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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