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Biopharmaceutical Manufacturing Associate III

Job ID: req1287
Employee Type: exempt full-time
Facility: Frederick: ATRF
Location: 8560 Progress Dr, Frederick, MD 21701 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 Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the National Cancer Institute (NCI) and other government agencies through the development of novel agents for first-in-man clinical studies.

KEY ROLES/RESPONSIBILITIES

The Manufacturing Associate III will:

  • Perform purification and aseptic fills of clinical, biological and natural products under cGMP conditions
  • Document in detail, through the use of master production records or laboratory notebooks, the processes and manufacturing steps taken during the procedures
  • Exercise judgment and use problem solving skills to obtain solutions and work independently to determine methods and procedures on new assignments
  • Train others within the working group
  • Set up, maintain and operate equipment used in the manufacture of clinical, biological and natural products, including the manufacture of products and in-process testing
  • Interface with Quality Control/Quality Assurance
  • Write Standard Operating Procedures and complete batch production records

BASIC QUALIFICATIONS

  • Possession of a Bachelor's degree from an accredited college/university in a field related to biomedical research or four years relevant experience in lieu of degree.
  • In addition to the education requirement, a minimum of five (5) years progressively responsible job-related experience
  • Demonstrated experience in the area of operating/maintaining computerized and complex production equipment such as chromatography instruments and aseptic filling machines
  • Experience writing/reviewing technical documents, SOPs and master production records and maintaining accurate documentation of laboratory procedures in accordance with cGMP
  • Working knowledge of cGMP Biopharmaceutical Sciences and operations 
  • Knowledge of or experience within a cGMP environment 
  • Ability to work flexible hours including occasional weekends
  • Ability to lift up to 35 pounds and work in a BL2 environment

PREFERRED QUALIFICATIONS

  • Experience with equipment used for downstream purification and clinical manufacturing
  • Ability to operate equipment such as Akta purification units, Bioprocessing purification units
  • Experience in Virus purification
  • Ability to perform in-process tests such as gel electrophoresis, HPLC, UV spectrophotometer measurement etc
  • Ability to pack various chromatography columns
  • Knowledge of department specific computer applications

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 atmospheric conditions that would require the usage of a respirator,
    requiring a medical clearance

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

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