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Associate Director/Director, Translational Bioanalytical Development

Boston, MA

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 for the right candidate this role can be remote. 

Job Summary 

GentiBio is seeking an experienced translational bioanalytical expert with a strong immunology background. The successful candidate will be responsible for developing an integrated bioanalytical program to support the preclinical through clinical development of programs. This individual will lead the development of bioanalytical assays to measure the cellular kinetics, immunogenicity, and expression of cells in various matrices. The role will allow for collaboration and cross-functional assay development with the manufacturing team. In addition, the successful candidate will manage one direct report (Analytical Outsourcing Manager) and be responsible for identifying opportunities to develop platform assays in support of multiple clinical programs. 

Job Responsibilities 

  • Develop cell-based and molecular assays for the in vivo measurement of cell therapies 
  • Work in a highly-matrix environment, including collaboration and assay co-development with CMC teams 
  • Problem-solve and monitor regulatory requirements for in vivo kinetics and immunogenicity assays needed to support INDs 
  • Provide strategic oversight to partner laboratories (external) and ensure validations are performed to regulatory standards
  • Manage outsourcing and BA contracts 
  • Establish LIMS systems for clinical PK and immunogenicity data 

Qualifications and Education Requirements 

  • PhD in pharmaceutical sciences or immunology with 7+ years of experience developing bioanalytical assays in industry 
  • Background in T cell biology preferred and experience working on cellular and/or gene therapies required 
  • Extensive experience developing multicolor flow cytometry assays, cell-based immunogenicity assays, and PCR-based assays for clinical use 
  • Experience validating assays to CLIA standards 
  • Experience managing relationships with CROs or experience serving as a project lead at a CRO 
  • Possess a strong immunology background and understand the strategic needs and relevance of the assays being developed   
  • Ability to work in a fast-paced environment and adapt to changes  
  • Exceptional teamwork and communication skills 
  • Demonstrated experience building and leading exceptional teams 
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