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

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

BASIC QUALIFICATIONS

• 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 with analytical 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

PREFERRED QUALIFICATIONS

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

JOB HAZARDS

• 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

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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