Chemistry

Senior Scientist, Analytical Development Direct Hire MA

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Job ID: 15782 Direct Hire MA

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Growing Gene Therapy company here in the Waltham, MA area is growing and looking to add a Sr. Scientist, Analytical Development to their team!  This role will work with others in the analytical development and quality control teams to develop late-stage assays for efficacy (potency), safety and product quality.  Other responsibilities include but not limited to:

  • Establish analytical capabilities to drive the company’s vector research and development strategy into action by developing analytical methods to support clinical and commercial development
  • Transfer of established methods to internal and external AD and QC departments
  • Implement basic analytical characterization and/or QC in-process and lot release methods
  • Working with the senior research staff, devise improvements in analytical methods, technology, and analysis platforms in support of cGMP vector manufacturing
  • Development, transfer and validation of quantitative cell-based potency assays that measure biological activity
  • Prepare, analyze and present technical data
  • Prepare and review technical reports and write SOPs
  • Work within a cross-functional team to drive programs forward

Requirements:

  • PhD in Cell Biology, Molecular Biology, Biochemistry, Virology or a related discipline with 3-6 years industry experience OR Masters with 7+ years industry experience.
  • Experience in mammalian cell culture, molecular biology, protein biochemistry, biophysical characterization, immunoassays and quantitative PCR methods
  • Experience in the development and qualification/validation of late-stage complex biological analytical assays
  • Experience with statistical analysis software (SoftMax, JMP, SAS) preferred
  • Experience with viral vectors is preferred, and experience with biologics is required
  • Experience working with external contract labs (CMOs, CROs) is a plus
  • Experience executing late-stage analytical comparability studies is preferred
  • Ability and desire to work in a fast-paced, start-up environment