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Principal Scientist, Product Characterization and Product Sciences

GentiBio

GentiBio

Product
Seattle, WA, USA
Posted on Tuesday, April 30, 2024
GentiBio is seeking a self-driven, collaborative, results-oriented and creative Immunologist to join our Analytical Development (AD) team as a Principal Scientist in Seattle to support GentiBio’s first engineered regulatory T-cells (EngTregs) program. As the lead of the Product Sciences and Characterization team, the incumbent will provide both strategic and execution leadership for the product characterization strategy and will help drive data-based decisions to optimize product quality. The incumbent will spend 50% of their time in the lab and 50% supporting strategic and operational activities. This role offers exposure to multiple facets of the organization, including cross-functional leadership, technical growth and an ample opportunity to be a high impact trailblazer in the emerging field of regulatory T-cell therapy.

Responsibilities

  • Foster a culture of seeking and giving help, inclusion, authenticity, and fun
  • Manage a team of high-functioning scientists accountable for cutting-edge functional and phenotypic characterization methods.
  • Develop complex flow cytometry and cell-based characterization methods evaluating drug product phenotype, functional and residuals.
  • Own the definition of EngTreg target drug product profile and product characterization strategy. Partner closely with Research and Translational teams to maintain alignment on the key EngTreg product attributes and best approaches to measure them.
  • Prepare for and oversee characterization testing of development and clinical drug product lots, including both CRO and internal lab preparation, testing, and data management.
  • Author regulatory filing content
  • Lead drug product characterization studies in close partnership with Process Development
  • Provide technical leadership on cross-functional teams by sharing expertise and experiences, and effectively communicating results.
  • With a cross-functional team, own the correlative analysis of the characterization data against clinical outcomes
  • Lay the groundwork for an effective drug product potency release testing strategy
  • Participate as a Treg biology expert in development or clinical investigations as needed
  • Contribute technical expertise to new technology due diligence efforts as needed

Qualifications & Education

  • Ph.D. in Immunology, Cell Biology, or equivalent discipline with 8+years of characterization experience of T-cell products, with at least 4 years in an industry setting
  • T cell biology expertise and experience developing T-cell characterization methods required.
  • Supervisory experience (>2-years) required
  • Experience developing complex cell-based and flow cytometry assays strongly preferred
  • Expertise in Treg biology preferred
  • Experience with statistical data analysis and mammalian gene editing systems preferred
  • Experience with CMC regulatory filings preferred
  • Exceptional teamwork and communication skills
  • Flexibility to pivot from plan A to plan B
  • Ability to synthesize complex information and focus on key deliverables
About us: 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. We are 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. Our corporate operations are in both Cambridge, MA and Seattle, WA.
We are building an exceptional company culture focused on empowerment, care for one another, an appreciation for diversity and inclusion, and the development of our people. We are looking for people who are not only incredible experts in their field, but also individuals who are looking to contribute to building and modeling an outstanding company culture – and having fun while doing so
Benefits: GentiBio benefits programs are designed to promote the health and well-being of our people and their families. We offer a competitive benefits package including a choice from 3 medical plan options, dental and vision plans, flexible spending accounts (FSAs), health saving accounts (HSAs) with employer contribution, disability & life insurances, 401(k) plan with company match, unlimited PTO, parental leave for delivering and non-delivering parents, commuter subsidy, and more!
EEO Statement: GentiBio is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.
Recruitment & staffing agencies: GentiBio does not accept agency resumes unless contacted directly by internal GentiBio Talent Acquisition. Please do not forward resumes to GentiBio employees or any other company location; GentiBio is not responsible for any fees related to unsolicited resumes.