QC Analyst IV - Bioanalytical (NCI)

Job Number:
Job Category:
Process Improvement / Quality Assurance
Day Job
Potential for Teleworking:
Clearance Level Must Currently Possess:
Clearance Level Must Be Able to Obtain:
Public Trust


The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.


QC Analyst IV-Bioanalytical

Reporting to the Manager of QC Bioanalytical, this position will:

  • Conduct routine and non-routine analysis of in-process, finished product, and stability samples according to Standard Operating Procedures (sops)
  • Ensure compliance with sops, FDA, CGMP and GLP regulations
  • Follow good documentation practices to ensure appropriate documentation of test results
  • Perform required data analysis, review data of moderate complexity, interpret data findings, investigate issues and report abnormalities, troubleshoot analytical methods
  • Prepare and submit data summaries of moderate complexity for review
  • Perform routine maintenance and troubleshooting on lab equipment
  • Participate in out-of-specification investigations and recommend corrective actions
  • Draft and revise Standard Operating Procedures (SOP’s)
  • Maintain the safety and orderliness of the lab
  • Perform method transfer and qualification activities
  • Work may be required on 2nd or 3rd shift and weekends as needed to support manufacturing activities



To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • 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
  • In addition to education requirements, a minimum of eight (8) years progressively responsible job-related experience in a cGMP environment
  • Must be able to obtain and maintain a security clearance
  • Knowledge of Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (cGMPs)
  • Ability to follow SOPs of simple to complex technical content and comply with cGMPs/GLPs
  • Extensive experience bioanalytical methods such as liquid chromatography systems to include HPLC and UPLC technologies, DNA analysis by PCR, Capillary Electrophoresis cIEF, and GXII
  • Strong technical writing skills
  • Cleanroom and BL2 experience
  • Ability to lift up to 35 pounds and work in a BL2 environment


Candidates with these desired skills will be given preferential consideration:

  • Experience with and/or knowledge of method qualification/validation, protein analysis, DNA analysis, or other large molecule experience
  • Experience with method transfer activities
  • Method development, instrument maintenance, and instrument and method troubleshooting

Expected Competencies:

  • Advanced level professional providing professional input to complex assignments/projects, providing direction to more junior professionals; while working independently receiving guidance in only the most complex situations
  • Exercises judgment in the evaluation, selection, and adaptation of both standard and complex techniques and procedures
  • Accountable for meeting own target timeline
  • Develops and manages operational initiatives to deliver tactical results
  • Advanced knowledge in a specialized field and broad knowledge of several related disciplines within a function
  • Understands the interrelationships of different disciplines, directs the application of existing principles and guides development of new policies and ideas
  • Implementation of solutions often requires a longer-term view, based on limited information, and take into consideration multiple perspectives and future implications
  • Solves complex problems; takes a broad perspective to identify solutions
  • Adapts style and uses persuasion in delivering messages on complex issues where audience perspectives will be divergent
  • A technical resource for colleagues with less experience; may direct the work of other staff members

Leidos Overview:
Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.
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