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Manufacturing Purification Associate

Job ID: req1969
Employee Type: nonexempt full-time
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.  

 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 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

Reporting to the Supervisor, Mfg. Purification Operations, the Manufacturing Associate I will:

  • Operate chromatography skids, tangential flow filtration skids, cGMP autoclaves, and basic laboratory equipment
  • Perform chromatography resin packing in various sizes and types of chromatography column hardware
  • Perform in-process sampling
  • Perform operation and changeover of equipment
  • Perform filter integrity testing
  • Follow Standard Operation Procedures (SOP)
  • Complete Batch Production Records under cGMP
  • Document in detail, using Batch Production Records or laboratory notebooks, the processes and manufacturing steps taken during the procedures

BASIC QUALIFICATIONS

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

  • Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree.  Foreign degrees must be evaluated for U.S. equivalency
  • No experience required beyond bachelor’s degree
  • Ability to be gown certified
  • Ability to lift up to 35 pounds
  • This position may require working on 2nd or 3rd shifts and weekends as needed
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Working knowledge of cGMPs and computer-assisted manufacturing and production equipment
  • Clean room and BL2 experience
  • Skills/experience in processes and equipment associated with column chromatography techniques from small to pilot scale
  • Experience in the operation of chromatography skids
  • Experience in the operation of tangential flow filtration skids
  • Experience in operation of UnicornTM software
  • Experience in chromatography column packing/qualification

 JOB HAZARDS

  • This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
  • This position is subject to the environmental conditions such as working outdoors, high humidity areas indoors, dampness and chilling, dry atmospheric conditions, etc. as part of the job

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

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