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QC Analyst III/IV (req2023)

Company: Frederick National Laboratory
Location: Frederick
Posted on: October 13, 2021

Job Description:


The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the National Cancer Institute (NCI) and other government agencies through the development of novel agents for first-in-man clinical studies.


  • cGMP Quality Control analyst for biopharmaceutical testing
  • Analytical support for the NCI CAR-T cell therapy program
  • Data analysis and writing technical reports
  • Develop, revise, and review SOPs, protocols, and technical reports
  • Support of QC functions (SOPs, logbooks, deviations, audits, investigations, CAPA, training, change control, and technical reports)
  • Performing instrument and assay validation or qualification procedures

This position may be filled with a QC Analyst III/IV commensuratewith the selected candidates experience:

  • Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
    • QC Analyst III - In addition to the education requirement, a minimum of five (5) years of progressively responsible experience
    • QC Analyst IV- In addition to the education requirement, a minimum of eight (8) years of progressively responsible experience
  • Hands-on laboratory experience in biomedical research/biotechnology/biopharmaceutical or related field
  • Extensive biotechnology field knowledge in analytical, biochemical and immunological testing
  • Ability to implement a rigorous testing program with appropriate operating procedures and cGMP compliance
  • Experience in data evaluation, trending and troubleshooting
  • Excellent technical writing skills
  • Proficiency withanalytical methods including flow cytometry, qPCR and spectrophotometry
  • Prior experience with instrument and process validation or qualification procedures
  • Knowledge of the USP, ICH and FDA guidelines related to product testing
  • Understanding of Current Good Manufacturing Processes (cGMP), Quality Control (QC), Standard Operating Procedure (SOP), CAR-T cell therapeutics, Antibody (mAb), Drug Product (DS), Drug Substance (DS), Active Pharmaceutical Ingredient (API), and validation (IQ/OQ/PQ)
  • Ability to obtain and maintain a security clearance


Candidates with these desired skills will be given preferential consideration:
  • Master's degree
  • Knowledge of GMPs, SOPs, good documentation practices and quality control operations
  • Experience with DNA, immunological and cell-based technology platforms
  • Proficiency with Microsoft Office, data analysis software, and other lab related applications
  • Strong written and verbal communication skills.
  • Experience with method development, qualification/validation
  • Proficiency with analytical methods including ligand-binding assays, FACS, PCR, spectrophotometry, bioassays, and liquid chromatography

  • This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
  • This position is subject to the environmental conditions such as working outdoors, high humidity areas indoors, dampness and chilling, dry atmospheric conditions, etc. as part of the job

Keywords: Frederick National Laboratory, Frederick , QC Analyst III/IV (req2023), Other , Frederick, Maryland

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