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QC Microbiology Analyst

Job ID: req1052
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:

  •  May be required to work 2nd or 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 enumeration of viable air samples, microbial identification, bioburden analysis, and media qualification
  •  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
  •  Perform microscopic techniques/cell counting, utility sampling, environmental monitoring
  •  Perform wet chemistry testing
  •  Be responsible for data documentation and technical writing
  •  Be responsible for daily laboratory maintenance tasks 

BASIC QUALIFICATIONS

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 (CHEA) in Microbiology or related field (4 years' closely related scientific experience in a 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 with 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 and ability to execute microbiology assay methodologies including enumeration, bioburden testing and media qualification
  •  Good technical writing skills
  •  Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • General knowledge of Biosafety Level 2 (BL2)
  •  Analytical equipment qualification
  •  Use of electronic systems E.g. MODA, LIMS
  • Experience with utility sampling/testing
  • Experience with gram staining
  • Experience and knowledge of traditional and rapid microbial methods
  •  Experience with microbial identification using a genetic analyzer
  •  Experience generating EM trend reports
  • Experience working in a pharmaceutical testing environment

JOB HAZARDS

  •  This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations

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