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QC Bioanalytical Analyst

Job ID: req1098
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

The QC Bioanalytical Analyst II 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
  •  Prepare and submit data summaries of moderate complexity for review
  •  Perform routine maintenance and troubleshooting on lab equipment
  •  Draft and revise SOPs
  •  Maintain the safety and orderliness of the lab
  •  Adhere to a high standard of documentation practices to ensure appropriate documentation of quality control test results
  •  Occasionally require non-regular work hours and weekends as needed to support manufacturing activities

BASIC QUALIFICATIONS

  •  Possession of a bachelor’s degree in a science related field from an accredited college or university (according to CHEA) or four (4) years of experience in lieu of degree. (Additional qualifying 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 2 years’ job-related experience
  •  Ability to follow SOPs and comply with cGMPs/GLPs
  •  Ability to work with electronic database systems such as LIMS
  •  General awareness of cGMP regulations
  •  Experience working with UPLC or HPLC systems
  •  Knowledge of general Bioanalytical laboratory equipment

PREFERRED QUALIFICATIONS

  •  Experience with basic laboratory techniques (e.g., buffer preparation, pH measurement)
  •  Basic knowledge of Bioanalytical methodology (e.g. PCR, ELISA, Electrophoresis, Spectrophotometry, UPLC/HPLC)
  • Detail oriented with strong organizational and verbal communication skills
  • Ability to work well in a team 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)