Sr. Scientist, Flow Cytometry

Our Cell Therapy client located in Cambridge, MA is growing and looking to add a Sr./Principal Scientist, Flow Cytometry to their Analytical Development team!  This role will be responsible for acting as a Team Lead, management of vendors including CRO's and characterization of their T cell products and development of in-process and release assays to support process development and manufacturing.

Responsibilities:

  • Build in-house technical capabilities with a focus on multiparameter flow cytometry (spectral- and compensation-based workflows) and high-dimensional data analysis for the characterization of process intermediates and drug products 
  • Lead the development and qualification of cell-based assays for cell therapy projects
  • Maintain and enhance current knowledge of emerging cellular phenotyping technologies in the field of immunotherapy bioanalytics to support improvements for existing analytical strategies
  • Select, design, and implement analytical methods to test raw materials, process intermediates, drug substances and drug products
  • Author standard operating procedures (SOPs), development, qualification, and validation reports; contribute to regulatory filings
  • Independently design and conduct experiments, complex assays and operational procedures
  • Effectively communicate complex scientific findings and recommendations in one-on-one discussions and at internal and external meetings
  • Transfer analytical methods to external/internal labs
Requirements:  
  • PhD in the biological sciences with minimum of 5 years, MS with 7 years or BS with 10+ years in flow cytometry and assay development in biotech, or equivalent experience
  • Previous experience in cell therapy with a strong background in immunology, T-cell biology, and/or CAR-T
    Extensive experience developing flow cytometry assays.
  • Experience with multiparameter flow cytometry (>15 fluorophores) essential; preference given to candidates with high parameter and spectral cytometry (30+ fluorophores) experience
  • Experience with BD Biosciences instrumentation (BD FACSymphony A5SE, BD FACSCanto II, BD LSRFortessa) preferred
  • Knowledge of flow cytometry data analysis software such as FACSDiva, FlowJo, OMIQ, FACSuite required; preference give to candidates with experience in high-dimensional data analysis paradigms such as FlowSOM, UMAP, tSNE Experience with assay and instrument qualification and validation; familiarity with FDA, ICH and GMP guidelines is a plus
  • Experience with techniques in molecular biology, such as RT-PCR, ddPCR, and/or protein analyses (ELISA, western blot) highly desired