Sr/Principal Scientist, Analytical Development (Flow Cytometry)

Our client located in Cambridge, MA is growing their Center of Excellence for Cell Therapy team; and looking for a hands-on, bench Sr./Principal Scientist, Analytical Development.  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:

  • Lead the development and qualification of assays for cell therapy projects with focus on flow cytometry 
  • 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
  • Design independently and conduct experiments, assays or operational procedures of considerable complexity with considerable discretion as to work details requiring complicated scientific analysis, operational planning and execution
  • Effectively communicate complex scientific findings and recommendations in one-on-one discussions and departmental functional and internal meetings
  • Transfer analytical methods to external/internal labs
  • Manage external vendors/labs (CROs/CMOs)
  • Mentor junior staff members.

Requirements:

  • PhD in the biological sciences with minimum of 4 years, MS with 8 years or BS with 10 years in assay development in biotech, or equivalent experience
  • Experience with techniques in molecular biology, such as RT-PCR, ddPCR, and/or protein analyses (ELISA, western blot) preferred
  • Experience with assay qualification and validation and familiarity with FDA, ICH and GMP guidelines is a plus
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities