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QC Microbiology Analyst II

Job ID: req916
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA

The Frederick National Laboratory is dedicated to improving human health through discovery and innovation in the biomedical sciences, focusing on cancer, AIDS, and emerging infectious diseases. 

Position Overview:

PROGRAM DESCRIPTION

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its’ mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and other bio-therapeutics to address infectious diseases of global significance (HIV-AIDS, Influenza, Ebola, Zika, Malaria and Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility engaged in GMP manufacture, testing, release and supply of Phase I /II clinical products for investigational use in the US and worldwide.

KEY ROLES/RESPONSIBILITIES

  • Reporting to the QC Microbiology Supervisor, the QC Microbiology Analyst will:
  • The schedule for this QC Analyst II will include weekends with flexibility in desired work week (example, 4 days 10-hours each Sat-Tues, or 5 days flexible hours Sat-Wed)
  • May be required to work 2ndor 3rd shift or early mornings as needed to support manufacturing activities
  • Perform routine testing of environmental samples, microbial analysis of water and compressed gasses, and microbial analysis of product samples
  • Perform required data analysis, compile data and prepare results for review
  • Conduct environmental enumeration of viable air samples, microbial identification, bioburden analysis, and sterility testing
  • Perform a variety of analyses including computer-based instrumental analytical methods
  • 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
  • Perform microscopic techniques/cell counting, utility sampling, environmental monitoring
  • Perform wet chemistry testing, chromatographic testing, spectroscopic testing
  • Use immunochemical methods
  • Be responsible for data documentation and technical writing
  • Be responsible for daily maintenance laboratory tasks

BASIC QUALIFICATIONS

  • Possession of a bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in Microbiology (Qualifying experience (4 years) in biology, microbiology, biochemistry or in a closely related science may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
  • In addition to the education requirement, a minimum of 2 years job-related experience
  • Experience in utility sampling/testing and environmental monitoring
  • Working knowledge of current Good Manufacturing Practices (cGMP) and scientific principles
  • Ability to develop analytical methods, generate and follow standard operating procedure (SOPs), and comply with cGMP regulations
  • Working knowledge of a laboratory environment and equipment used for pharmaceutical analysis
  • Experience working in a pharmaceutical testing environment
  • Experience and ability to execute microbiology assay methodologies including enumeration, gram staining, microbial identification, microbial limits and the ability to subculture
  • Good technical writing skills
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

  • General knowledge of Biosafety Level 2 (BL2)
  • Analytical equipment qualification
  • Use of electronic systems E.g. MODA, LIMS
  • Experience and knowledge of traditional and Rapid Microbial ID Methods
  • Experience with genotyping of microorganisms

JOB HAZARDS OR REQUIREMENTS

  • Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)