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Scientist/Senior Scientist, Analytical Chemistry and Assay 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 an experienced and motivated Scientist/Senior Scientist with a strong background in chemistry or biochemistry to join our Analytical Development (AD) team in Seattle. The successful candidate will lead the development of biochemical assays in support of GentiBio’s first engineered regulatory T-cells (EngTregs) program. This lab-based 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 
  • Drive the technical strategy for use of biochemical assays and lead the development of MS- and HPLC-based methods for drug product release and characterization of process residuals 
  • Ensure methods are qualified as per regulatory guidance and documented in qualification reports 
  • Closely collaborate with Research, Translational, and Process Development teams to align on the key EngTreg product attributes and best approaches to measure them 
  • Communicate results to cross-functional teams 
  • Develop method SOPs and support method transfer to the clinical manufacturing facility 
  • Participate as a biochemical analysis subject matter expert in investigations as needed 
  • Contribute content to regulatory filings  
  • Contribute to the build of the cell therapy development laboratory from lab layout to mapping out of analytical workflows 
  • Opportunity to manage and mentor junior scientists 
  • Contribute technical expertise to new technology due diligence efforts as needed 

Qualifications and Education Requirements 

  • Ph.D in chemistry, biochemistry or related field with 2+ years of experience, or BS/MS with 6+ years of experience in analytical development within biotech, pharma, or contract research organization
  • Experience with analytical characterization in support of small molecule drugs or biologics (proteins, antibodies, enzymes, cell therapies) development
  • Comprehensive knowledge and technical expertise in HPLC analysis
  • Strong background in MS analysis and experience with LC-MS systems, including familiarity with instrumentation and knowledge of data analysis approaches require
  • Experience developing biochemical methods for the detection of proteins, small molecules, and process impurities in a pharmaceutical setting required
  • Experience with statistical data analysis and development of residual clearance models preferred 
  • Experience with 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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