Job Details - Manufacturing Associate I or - 43281405 | Frederick National Laboratory Talent Network
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Manufacturing Associate I or II in Frederick, MD

Location: Frederick, MD
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech

Description

PROGRAM DESCRIPTION         

The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the Frederick National Laboratory for Cancer Research (FNLCR) 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
  • 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
  • cGMP conditions

 BASIC QUALIFICATIONS

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

Assoc II, Manuf:

  • Possession of a (CHEA) 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
  • A minimum of two (2) years related work experience

Assoc I, Manuf:

  • Possession of a (CHEA) 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
  • Ability to work flexible hours including occasional weekends
  • Ability to obtain and maintain a security clearance 

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:  

  • Aseptic technique
  • Strong math skills
  • Interest in cell culture, cell therapy and virus production

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
  • This position is subject to working with radioactive material and requires to become an approved
    radiation worker


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