QC Microbiology Analyst in Frederick, MD

Description

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 biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.

KEY ROLES/RESPONSIBILITIES

• May assure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma)
  
• May be required to work 2nd or 3rd shift or early mornings as needed to support manufacturing activities
  
• Performs routine testing of environmental samples, microbial analysis of water and compressed gasses, and microbial analysis of product samples
  
• Performs required data analysis, compile data and prepare results for review
  
• Conducts enumeration of viable air samples, microbial identification, bioburden analysis, and media qualification
  
• Participates in internal assessments and audits
  
• Plans own activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities
  
• Interprets test results, compare to established specifications and control limits
  
• Performs microscopic techniques/cell counting, utility sampling, environmental monitoring
  
• Performs wet chemistry testing
  
• Will be responsible for data documentation and technical writing
  
• Will 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 a scientific related field (Qualifying four (4) years equivalent, directly relevant, experience 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 two (2) years of job-related experience
  
• Experience with environmental monitoring
  
• Working knowledge of current Good Manufacturing Practices (cGMP) and scientific principles
  
• Ability to generate and follow standard operating procedure (SOPs), and comply with cGMP regulations
  
• Working knowledge of a laboratory environment and equipment used for pharmaceutical analysis
  
• Ability to execute microbiology assay methodologies including enumeration, gram staining microbial limits and the ability to subculture
  
• Good technical writing skills
  
• Experience working in a pharmaceutical testing environment
  
• Ability 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 in and ability to execute bioburden testing, sterility testing and media qualification

JOB HAZARDS

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