Quality Control Analyst in Durham

Job Description

Position Summary:

\n

\n
• 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.

\n

• 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.

\n

\n

\n

Job Responsibilities:

\n

\n
• Perform routine and complex execution of molecular biology and biochemistry analytical methods such as qPCR, d/ddPCR, ELISA, HPLC, endotoxin etc.

\n

• Organize and perform data analysis at completion of each test method, peer review data.

\n

• Assist with evaluation of analytical results and final reports.

\n

• Follow SOPs and document analytical test method procedures.

\n

• Assist with revisions of work instructions, SOPs, forms, reports, and electronic laboratory notebook analytical records.

\n

• Contribute to technical discussions and investigations.

\n

• Assist with management of raw materials, analytical test method supplies, and samples as needed.

\n

• Ensure lab areas are clean, organized and equipment, supplies and raw materials are available for use.

\n

\n

\n

Minimum Requirements:

\n

\n
• Bachelor’s degree in biology or related field.

\n

\n

\n

Education, Experience and Skills:

\n

\n
• Relevant work experience (0-3 years) in areas such as, analytical testing, development, and technology transfer; in rAAV/gene therapy, recombinant protein/biomolecules, and/or other advanced therapeutic modalities.

\n

• Experience with electronic laboratory notebooks is a plus.

\n

\n