Manufacturing Associate III/IV (req2089)

Company: Frederick National Laboratory
Location: Frederick
Posted on: October 13, 2021

Job Description:

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 virus production and purification under cGMP conditions
• Assist in set up and commissioning of new cell therapy production suites

• 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
  • Manufacturing Associate III - In addition to the education requirement, a minimum of five (5) years of progressively responsible experience
  • Manufacturing Associate IV - In addition to the education requirement, a minimum of eight (8) 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
• Ability to work flexible hours including occasional weekends
• Ability to lift up to 35 pounds and work in a BL2 environment
• Ability to obtain and maintain a security clearance

• Experience in virus production/purification
• Experience with technical transfer of GMP production processes

• 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 III/IV (req2089), Other , Frederick, Maryland