Manufacturing Associate II/III (req2086)

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 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

• Responsible for performing production of clinical biological products under CGMP conditions
• Must be able to document in detail, through the use of master production records or laboratory notebooks, the processes and manufacturing steps taken during the procedures
• Must be able to solve problems of a very complex scope, exercise independent judgement and work independently on new projects
• Will be responsible for training others within this group
• Responsible for setting up, maintenance and operation of related equipment
• Will interface with Quality Control/Quality Assurance, write standard SOP's and review batch records
• May be required to supervise the activities of lower lever personnel

• 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 II - In addition to the education requirement, a minimum of two (2) years of progressively responsible experience
  • Manufacturing Associate III - In addition to the education requirement, a minimum of five (5) years of progressively responsible experience
• 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 25 pounds and work in a BL2 environment
• Ability to obtain and maintain a security clearance
• Should be able to operate computerized production equipment, i.e AKTA Pilots, AKTA Process etc.
• Interface with other departments
• Work flexible hours, including weekends and evenings
• Work in a BL2 environment
• Train other personnel

• Knowledge of CGMP Biopharmaceutical Sciences and operations
• Laboratory environment and equipment used for pharmaceutical production
• A minimum of 8 years related experience with a Bachelors degree, or 5 to 8 years related experience with a Masters and demonstrated working knowledge of scientific principles
• Knowledge of Virus production and Virus Purification
• Experience with large scale chromatography equipment and systems
• Experience in virus production/purification
• Experience with technical transfer of GMP production processes
• Ability to perform in-process tests such as gel electrophoresis, HPLC, Elisa, Western blot, SDS-PAGE etc.

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations

Keywords: Frederick National Laboratory, Frederick , Manufacturing Associate II/III (req2086), Other , Frederick, Maryland