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Senior Director, CMC Strategy and Lifecycle Management

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 collaborative and self-driven cell therapy CMC strategy expert to join our Technical Operations team in Seattle as the Sr. Director, Head of CMC Strategy and Lifecycle Management. This role offers exposure to multiple facets of an organizational and company build, a prominent leadership role within Technical Operations and company at large, 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 
  • Map out and own CMC strategy and lifecycle management roadmap for all GentiBio clinical programs 
  • Closely interface with program and research leadership as well as CMC Regulatory and Regulatory Affairs to ensure that CMC strategy is aligned with portfolio and regulatory strategies and timelines 
  • Develop phase-appropriate CMC playbooks including decision making frameworks 
  • Lead a cross-functional CMC team for GentiBio’s first clinical EngTreg program and ensure that CMC strategy is aligned with the overall program goals 
  • Present CMC project updates to GentiBio leadership team and other key stakeholders  
  • Closely collaborate with other members of Technical Operations leadership team to foster a collaborative, transparent, and inclusive Technical Operations team culture 
  • Grow an organization composed of project managers and CMC leads 
  • Contribute CMC expertise to due diligence and collaboration initiatives  

Educational Qualification And Requirements 

  • BS/MS/PhD in a relevant Science or Engineering discipline with 15+ years of relevant industry experience  
  • Previous experience leading cell therapy CMC strategy required 
  • Experience serving as a key contributor to regulatory filings required 
  • Ability to synthesize multiple inputs into key CMC deliverables 
  • Previous experience with gene-edited T-cell products and management of CDMO collaborations strongly preferred 
  • Familiarity with Treg products preferred but not required 
  • Exceptional communication skills and strong adaptability to changes 
  • Demonstrated ability to work collaboratively with others to solve complex problems 
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