Scientist I/II, Analytical Development | ClinLab Staffing

Position Summary:

We are seeking a highly motivated Scientist to join our Analytical Development team. The selected candidate will be responsible for characterization of our BOXR T cell products and development of in-process and release assays to support process development and manufacturing. The successful candidate will work in a highly cross-functional manner with members of Research, Translational Medicine, Process Development and Manufacturing as well as with external CROs

Key Activities and Responsibilities:

  • Use state-of the art cellular, proteomic and molecular tools to assess key attributes of the BOXR cellular therapy product
  • Select, design and implement analytical methods to test process intermediates, drug substances and drug products
  • Support specification setting, qualification and validation of assays
  • Write protocols and development reports, and contribute to relevant regulatory filings
  • Tech transfer selected assays to in-house and CMO QC groups
  • Present scientific results in team meetings and at conferences
  • Other duties as assigned

Competences, Skills and Qualification:

  • PhD in the biological sciences with minimum of 2 years, MS with 6 years or BS with 10 years in assay development in biotech, or equivalent experience
  • Expertise in flow cytometry required
  • Experience with techniques in molecular biology, such as RT-PCR and/or protein analyses (ELISA, western blot) highly desired
  • 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
  • Strong organizational and record-keeping skills
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

Physical Requirements:

  •    Prolonged periods of sitting at a desk, standing in a lab and working on a computer.
  •    Ability to safely travel to various physical locations.
  •    Must be able to lift 15 pounds at times.
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