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Quality Control Analyst I

LeadStack Inc.

Quality Control Analyst

The purpose of the Analyst I, Quality Control (Non-Clinical) is to perform analytical testing to support the release of Non-Clinical grade rAAV vector lots manufactured in various departments (including, Pre-Clinical Manufacturing, Process Development, MSAT) and external partners. The rAAV vectors tested/characterized by the team will support capsid technology development, intellectual property portfolio, and internal progression of early-stage gene therapy programs.

Job Responsibilities

  • Perform routine and complex execution of molecular biology and biochemistry analytical methods such as qPCR, d/ddPCR, ELISA, HPLC, endotoxin etc.
  • Organize and perform data analysis at completion of each test method, peer review data.
  • Assist with evaluation of analytical results and final reports.
  • Follow SOPs and document analytical test method procedures.
  • Assist with revisions of work instructions, SOPs, forms, reports, and electronic laboratory notebook analytical records.
  • Contribute to technical discussions and investigations.
  • Assist with management of raw materials, analytical test method supplies, and samples as needed.
  • Ensure lab areas are clean, organized and equipment, supplies and raw materials are available for use.

Minimum Requirements

  • Bachelor's degree in biology or related field.

Preferred Education, Experience and Skills

  • Relevant work experience (0-2 years) in areas such as, analytical testing, development, and technology transfer; in rAAV/gene therapy, recombinant protein/biomolecules, and/or other advanced therapeutic modalities.
  • Experience with electronic laboratory notebooks is a plus
Vacancy posted 5 days ago
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