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Manufacturing Associate II/III (req1937)

Company: Frederick National Laboratory
Location: Frederick
Posted on: July 20, 2021

Job Description:

PROGRAM DESCRIPTION

The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the Frederick National Lab for Cancer Research (FNLCR) and other government agencies through the development of novel agents for first-in-human 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
  • 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

Level III willtrain others within the working groupBASIC QUALIFICATIONS

This position may be filled with a Manufacturing Associate II/III commensuratewith the selected candidates experience.

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
  • Aseptic technique
  • 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
    • Level II - In addition to the education requirement, a minimum of two (2) years of progressively responsible experience
    • Level III - In addition to the education requirement, a minimum of five (5) years of progressively responsible experience
    • 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

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:
  • 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


Keywords: Frederick National Laboratory, Frederick , Manufacturing Associate II/III (req1937), Other , Frederick, Maryland

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