Quality Control (QC) Analyst - analytical assay, clinical trials
analytical assay, clinical trials, biosafety, manufacturing
Our scientists can’t do it alone. It takes a skilled, multi-disciplinary team of dedicated staff in research, patient care and administration to improve the lives of cancer patients and answer the most important questions in cancer biology and treatment. Be part of our mission to unlock the mysteries of cancer through research to create the medicines of tomorrow.
The Clinical Research Directorate (CRD) provides analytical experience to work on innovative T-cell therapy for cancer treatment, and responsible for development and execution of analytical assays for generation lot release assays and product CoAs in support of the National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR), Surgery Branch (SB).
- Perform QC testing of materials manufactured for first-in-human immunotherapy clinical trials
- Perform cell culture of human primary cells, ELISA, FACS, PCR and qPCR assays as required for lot release
- Perform required data analysis, compile data and prepare results for review
- Participate in internal assessments and audits
- Plan own activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities
- Interpret test results, compare to established specifications and control limits and makes recommendations on appropriateness of data for release
- Train new employees as required on techniques and SOPs
- Be responsible for data documentation and technical writing
- Be responsible for daily maintenance laboratory tasks
- Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education)
- Foreign degrees must be evaluated for U.S. equivalency
- No experience required with a Bachelor’s degree
- Working knowledge of current Good Manufacturing Practices (cGMP) and scientific principles
- Ability to follow SOPs and comply with cGMP regulations
- Develop analytical methods and generate SOPs
- Perform a variety of analyses including computer-based instrumental analytical methods
- Good technical writing skills
- Must be able to obtain and maintain a security clearance
- General knowledge of Biosafety Level 2 (BL2)
- Analytical equipment qualification
- Demonstrated ability to interface with Manufacturing, Quality Assurance, Materials Management
Please reference job id req636 for all inquiries.
Hiring for this position will be through Leidos Biomedical Research, Inc., a wholly owned subsidiary of Leidos, Inc. Leidos Biomedical is the operations and technical support contractor for the Frederick National Laboratory for Cancer Research, a federal national laboratory.
Bethesda is located adjacent to Washington, D.C. and is an urban core of Montgomery County, MD. Bethesda is one of the most affluent and highly educated communities in the United States. It is a vibrant town, and a destination for shopping, dining and artistic and cultural events.
HHS, NIH, and NCI are Equal Opportunity Employers