Quality Control Analyst
ALOIS Solutions
Durham, NC0–3 yrs1h agovia LinkedIn
About the Role
- The Analyst I, Quality Control (Non-Clinical) performs 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 will support capsid technology development, intellectual property portfolio, and internal progression of early-stage gene therapy programs.
Key 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.
- Ensure lab areas are clean, organized, and equipment, supplies, and raw materials are available for use.
Requirements & Tech Stack
- qPCR
- d/ddPCR
- ELISA
- HPLC
- Endotoxin testing
- SOPs
- Electronic laboratory notebooks (preferred)
Qualifications
- Bachelor’s degree in biology or related field.
- 0-3 years of relevant work experience in areas such as analytical testing, development, and technology transfer.
- Experience in rAAV/gene therapy, recombinant protein/biomolecules, and/or other advanced therapeutic modalities is preferred.