QC Analyst III / IV (req1833)

Company: Frederick National Laboratory
Location: Frederick
Posted on: July 20, 2021

Job Description:

PROGRAM 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.

KEY ROLES/RESPONSIBILITIES

• 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

• 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

• 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 (req1833), Other , Frederick, Maryland