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Manufacturing Associate III/IV

Job ID: req1201
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

  • All phases of production of clinical, biological 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 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
  • Assist in the development of procedures to perform cell therapy under cGMP conditions
  • Assist in set up and commissioning of new cell therapy production suites

 BASIC QUALIFICATIONS

Level III

  • Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the education requirements, a minimum of five (5) years related experience

Level IV

  • Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the education requirements, a minimum of eight (8) years of experience is required

Both Levels

  • Demonstrated experience in the area of operating/maintaining computerized and complex production equipment
  • 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 and department specific computer applications
  • Ability to work flexible hours including occasional weekends
  • Ability to lift up to 35 pounds and work in a BL2 environment
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

  •  Experience with cell therapy equipment and systems
  • Experience in virus production/purification
  • Experience with technical transfer of GMP production processes

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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